Nivolumab or Nivolumab Plus Cisplatin, in Combination Wit... | NCT03349710

ID	Type	Description	Link
2017-002676-87	EudraCT Number

Name	Class
Ono Pharmaceutical Co., Ltd.	INDUSTRY

Label	Type	Description	Intervention Names
Arm A	Experimental	Cohort 1	Biological: Nivolumab Radiation: Radiotherapy
Arm B	Experimental	Cohort 1	Drug: Cetuximab Radiation: Radiotherapy
Arm C	Experimental	Cohort 2	Biological: Nivolumab Drug: Cisplatin Radiation: Radiotherapy
Arm D	Experimental	Cohort 2	Drug: Cisplatin Radiation: Radiotherapy

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Biological	Specified dose on specified day	Arm A Arm C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With an Adverse Event (AE)	Number of Participants with an Adverse Event	30 Days
Number of Participants With an Serious Adverse Event (SAE)	Number of Participants with an Serious Adverse Event (SAE)	30 days
Number of Participants With an Adverse Event Leading to Discontinuation	Number of Participants with an Adverse Event Leading to Discontinuation	30 Days
Number of Participants With an Adverse Event Leading to Dose Modification	Number of Participants with an Adverse Event Leading to dose modification	30 Days
Number of Participants With Select Adverse Events	Number of Participants with select adverse events. Select Adverse events include: gastrointestinal, hepatic, hypersensitivity/infusion reaction, pulmonary, renal, or skin.	30 Days
Number of Participants With an Immune-mediated Adverse Event (IMAE)	Number of Participants with an immune-mediated adverse event (IMAE)	100 days
Time to Onset and Time to Resolution of Immune-related Adverse Events	Time to onset and time to resolution of immune-related adverse events	100 days

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

Facility	Status	City	State	ZIP	Country	Contacts
Pinnacle Research Group, Llc		Anniston	Alabama	36207	United States
Cancer Treatment Centers of Phoneix

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

ID	Title	Description
FG000	Arm A (Cohort 1)	Nivolumab + Radiotherapy
FG001	Arm B (Cohort 1)	Cetuximab + Radiotherapy

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 16, 2018	Jun 25, 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

Number of Participants With an Adverse Event (AE)

Number of Participants with an Adverse Event

All Treated Participants

Posted

Count of Participants

Participants

30 Days

ID	Title	Description
OG000	Arm A (Cohort 1)	Nivolumab + Radiotherapy
OG001	Arm B (Cohort 1)	Cetuximab + Radiotherapy
OG002	Arm C (Cohort 2)	Cisplatin + Nivolumab + Radiotherapy
OG003	Arm D (Cohort 2)	Cisplatin + Radiotherapy

Units	Counts
Participants	OG00012 OG00110 OG00227 OG003

Title

Denominators

Categories

Title	Measurements
	OG00012 OG00110 OG00227 OG003

Primary

Number of Participants With an Serious Adverse Event (SAE)

Number of Participants with an Serious Adverse Event (SAE)

All Treated Participants

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	Arm A (Cohort 1)	Nivolumab + Radiotherapy
OG001	Arm B (Cohort 1)	Cetuximab + Radiotherapy
OG002	Arm C (Cohort 2)	Cisplatin + Nivolumab + Radiotherapy
OG003	Arm D (Cohort 2)	Cisplatin + Radiotherapy

Units	Counts
Participants

Primary

Number of Participants With an Adverse Event Leading to Discontinuation

Number of Participants with an Adverse Event Leading to Discontinuation

All Treated Participants

Posted

Count of Participants

Participants

30 Days

ID	Title	Description
OG000	Arm A (Cohort 1)	Nivolumab + Radiotherapy
OG001	Arm B (Cohort 1)	Cetuximab + Radiotherapy
OG002	Arm C (Cohort 2)	Cisplatin + Nivolumab + Radiotherapy
OG003	Arm D (Cohort 2)	Cisplatin + Radiotherapy

Units	Counts
Participants

Primary

Number of Participants With an Adverse Event Leading to Dose Modification

Number of Participants with an Adverse Event Leading to dose modification

All Treated Participants

Dose levels were maintained, no dose modification occurred

Posted

Count of Participants

Participants

30 Days

ID	Title	Description
OG000	Arm A (Cohort 1)	Nivolumab + Radiotherapy
OG001	Arm B (Cohort 1)	Cetuximab + Radiotherapy
OG002	Arm C (Cohort 2)	Cisplatin + Nivolumab + Radiotherapy
OG003	Arm D (Cohort 2)	Cisplatin + Radiotherapy

Units	Counts
Participants

Primary

Number of Participants With Select Adverse Events

Number of Participants with select adverse events.

Select Adverse events include: gastrointestinal, hepatic, hypersensitivity/infusion reaction, pulmonary, renal, or skin.

All Treated Participants

Posted

Count of Participants

Participants

30 Days

ID	Title	Description
OG000	Arm A (Cohort 1)	Nivolumab + Radiotherapy
OG001	Arm B (Cohort 1)	Cetuximab + Radiotherapy
OG002	Arm C (Cohort 2)	Cisplatin + Nivolumab + Radiotherapy
OG003	Arm D (Cohort 2)	Cisplatin + Radiotherapy

Units	Counts
Participants

Primary

Number of Participants With an Immune-mediated Adverse Event (IMAE)

Number of Participants with an immune-mediated adverse event (IMAE)

All Treated Participants

Posted

Count of Participants

Participants

100 days

ID	Title	Description
OG000	Arm A (Cohort 1)	Nivolumab + Radiotherapy
OG001	Arm B (Cohort 1)	Cetuximab + Radiotherapy
OG002	Arm C (Cohort 2)	Cisplatin + Nivolumab + Radiotherapy
OG003	Arm D (Cohort 2)	Cisplatin + Radiotherapy

Units	Counts
Participants

Primary

Time to Onset and Time to Resolution of Immune-related Adverse Events

Time to onset and time to resolution of immune-related adverse events

All Treated Participants - Insufficient amount of participants with IMAEs for time to onset and time to resolution

Posted

100 days

ID	Title	Description
OG000	Arm A (Cohort 1)	Nivolumab + Radiotherapy
OG001	Arm B (Cohort 1)	Cetuximab + Radiotherapy
OG002	Arm C (Cohort 2)	Cisplatin + Nivolumab + Radiotherapy
OG003	Arm D (Cohort 2)	Cisplatin + Radiotherapy

Units	Counts
Participants

Primary

Number of Participants Who Experienced Death

Number of Participants who experienced death

All Treated Participants

Posted

Count of Participants

Participants

100 days

ID	Title	Description
OG000	Arm A (Cohort 1)	Nivolumab + Radiotherapy
OG001	Arm B (Cohort 1)	Cetuximab + Radiotherapy
OG002	Arm C (Cohort 2)	Cisplatin + Nivolumab + Radiotherapy
OG003	Arm D (Cohort 2)	Cisplatin + Radiotherapy

Units	Counts
Participants

Primary

Number of Participants With an Abnormality in Specific Thyroid Tests

Number of participants with an abnormality in specific thyroid tests

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

Posted

Count of Participants

Participants

30 Days

ID	Title	Description
OG000	Arm A (Cohort 1)	Nivolumab + Radiotherapy
OG001	Arm B (Cohort 1)	Cetuximab + Radiotherapy
OG002	Arm C (Cohort 2)	Cisplatin + Nivolumab + Radiotherapy
OG003	Arm D (Cohort 2)	Cisplatin + Radiotherapy

Units	Counts
Participants

Primary

Number of Participants With an Abnormality in Specific Liver Tests

Number of participants with an abnormality in specific liver tests

All Treated Participants

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	Arm A (Cohort 1)	Nivolumab + Radiotherapy
OG001	Arm B (Cohort 1)	Cetuximab + Radiotherapy
OG002	Arm C (Cohort 2)	Cisplatin + Nivolumab + Radiotherapy
OG003	Arm D (Cohort 2)	Cisplatin + Radiotherapy

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG0030 affected24 at risk
Cardiac failure	Cardiac disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Myocardial infarction	Cardiac disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Dysphagia	Gastrointestinal disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Nausea	Gastrointestinal disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Small intestinal haemorrhage	Gastrointestinal disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Stomatitis	Gastrointestinal disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Death	General disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Oedema peripheral	General disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Pyrexia	General disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Bacillus bacteraemia	Infections and infestations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Bronchitis bacterial	Infections and infestations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Clostridium difficile colitis	Infections and infestations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Mucosal infection	Infections and infestations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Pneumonia	Infections and infestations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Sepsis	Infections and infestations	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Septic shock	Infections and infestations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Urinary tract infection bacterial	Infections and infestations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Skull fracture	Injury, poisoning and procedural complications	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Alanine aminotransferase increased	Investigations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Aspartate aminotransferase increased	Investigations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Platelet count decreased	Investigations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Transaminases increased	Investigations	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Dehydration	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Malnutrition	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Oropharyngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Cerebrovascular accident	Nervous system disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Headache	Nervous system disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Delirium	Psychiatric disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Psychotic disorder	Psychiatric disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Acute kidney injury	Renal and urinary disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0022 affected27 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Pharyngeal necrosis	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Rash	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Hypotension	Vascular disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	22.1	Systematic Assessment	EG0004 affected12 at risk EG0013 affected10 at risk EG00212 affected27 at risk EG0038 affected24 at risk
Leukocytosis	Blood and lymphatic system disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Leukopenia	Blood and lymphatic system disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0022 affected27 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected10 at risk EG0022 affected27 at risk EG003
Neutropenia	Blood and lymphatic system disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0023 affected27 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Deafness	Ear and labyrinth disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0022 affected27 at risk EG003
Ear pain	Ear and labyrinth disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Tinnitus	Ear and labyrinth disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0025 affected27 at risk EG003
Hyperthyroidism	Endocrine disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0024 affected27 at risk EG003
Hypothyroidism	Endocrine disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0026 affected27 at risk EG003
Dry eye	Eye disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0012 affected10 at risk EG0020 affected27 at risk EG003
Vision blurred	Eye disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Cheilitis	Gastrointestinal disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Constipation	Gastrointestinal disorders	22.1	Systematic Assessment	EG0004 affected12 at risk EG0012 affected10 at risk EG00213 affected27 at risk EG003
Diarrhoea	Gastrointestinal disorders	22.1	Systematic Assessment	EG0004 affected12 at risk EG0013 affected10 at risk EG0022 affected27 at risk EG003
Dry mouth	Gastrointestinal disorders	22.1	Systematic Assessment	EG0004 affected12 at risk EG0013 affected10 at risk EG00212 affected27 at risk EG003
Dyspepsia	Gastrointestinal disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0021 affected27 at risk EG003
Dysphagia	Gastrointestinal disorders	22.1	Systematic Assessment	EG0006 affected12 at risk EG0013 affected10 at risk EG00211 affected27 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Glossodynia	Gastrointestinal disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Lip dry	Gastrointestinal disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Nausea	Gastrointestinal disorders	22.1	Systematic Assessment	EG0003 affected12 at risk EG0011 affected10 at risk EG00217 affected27 at risk EG003
Odynophagia	Gastrointestinal disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0027 affected27 at risk EG003
Oesophagitis	Gastrointestinal disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Oral pain	Gastrointestinal disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0012 affected10 at risk EG0020 affected27 at risk EG003
Saliva altered	Gastrointestinal disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Stomatitis	Gastrointestinal disorders	22.1	Systematic Assessment	EG0004 affected12 at risk EG0014 affected10 at risk EG00210 affected27 at risk EG003
Vomiting	Gastrointestinal disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected10 at risk EG0026 affected27 at risk EG003
Asthenia	General disorders	22.1	Systematic Assessment	EG0002 affected12 at risk EG0010 affected10 at risk EG0022 affected27 at risk EG003
Fatigue	General disorders	22.1	Systematic Assessment	EG0004 affected12 at risk EG0015 affected10 at risk EG0028 affected27 at risk EG003
Gait disturbance	General disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Malaise	General disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Mucosal inflammation	General disorders	22.1	Systematic Assessment	EG0002 affected12 at risk EG0012 affected10 at risk EG0027 affected27 at risk EG003
Oedema peripheral	General disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Pain	General disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0022 affected27 at risk EG003
Pyrexia	General disorders	22.1	Systematic Assessment	EG0002 affected12 at risk EG0012 affected10 at risk EG0024 affected27 at risk EG003
Xerosis	General disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0021 affected27 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Hypersensitivity	Immune system disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Bacterial infection	Infections and infestations	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Conjunctivitis	Infections and infestations	22.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Herpes simplex	Infections and infestations	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Infected dermal cyst	Infections and infestations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Mucosal infection	Infections and infestations	22.1	Systematic Assessment	EG0002 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Nasopharyngitis	Infections and infestations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Oral candidiasis	Infections and infestations	22.1	Systematic Assessment	EG0002 affected12 at risk EG0011 affected10 at risk EG0022 affected27 at risk EG003
Paronychia	Infections and infestations	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Pyoderma	Infections and infestations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Skin infection	Infections and infestations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Subcutaneous abscess	Infections and infestations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Wound infection	Infections and infestations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Contusion	Injury, poisoning and procedural complications	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0022 affected27 at risk EG003
Incision site inflammation	Injury, poisoning and procedural complications	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	22.1	Systematic Assessment	EG0000 affected12 at risk EG0012 affected10 at risk EG0020 affected27 at risk EG003
Radiation mucositis	Injury, poisoning and procedural complications	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Radiation skin injury	Injury, poisoning and procedural complications	22.1	Systematic Assessment	EG0004 affected12 at risk EG0015 affected10 at risk EG0028 affected27 at risk EG003
Recall phenomenon	Injury, poisoning and procedural complications	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Stoma site inflammation	Injury, poisoning and procedural complications	22.1	Systematic Assessment	EG0002 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Alanine aminotransferase increased	Investigations	22.1	Systematic Assessment	EG0001 affected12 at risk EG0012 affected10 at risk EG0022 affected27 at risk EG003
Aspartate aminotransferase increased	Investigations	22.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected10 at risk EG0022 affected27 at risk EG003
Blood creatinine increased	Investigations	22.1	Systematic Assessment	EG0002 affected12 at risk EG0011 affected10 at risk EG0028 affected27 at risk EG003
Blood electrolytes abnormal	Investigations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Blood magnesium decreased	Investigations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Blood thyroid stimulating hormone decreased	Investigations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0022 affected27 at risk EG003
Blood thyroid stimulating hormone increased	Investigations	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Blood urea increased	Investigations	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
C-reactive protein increased	Investigations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Lipase increased	Investigations	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Lymphocyte count decreased	Investigations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0024 affected27 at risk EG003
Neutrophil count decreased	Investigations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0029 affected27 at risk EG003
Platelet count decreased	Investigations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0023 affected27 at risk EG003
Protein total decreased	Investigations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Weight decreased	Investigations	22.1	Systematic Assessment	EG0003 affected12 at risk EG0012 affected10 at risk EG00211 affected27 at risk EG003
White blood cell count decreased	Investigations	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0027 affected27 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0004 affected12 at risk EG0012 affected10 at risk EG0029 affected27 at risk EG003
Dehydration	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0022 affected27 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected10 at risk EG0024 affected27 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0002 affected12 at risk EG0011 affected10 at risk EG0025 affected27 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0013 affected10 at risk EG0024 affected27 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0002 affected12 at risk EG0010 affected10 at risk EG0022 affected27 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected10 at risk EG0021 affected27 at risk EG003
Malnutrition	Metabolism and nutrition disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0022 affected27 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0023 affected27 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0022 affected27 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0004 affected12 at risk EG0011 affected10 at risk EG0022 affected27 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Trismus	Musculoskeletal and connective tissue disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Pyogenic granuloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Dizziness	Nervous system disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0021 affected27 at risk EG003
Dysgeusia	Nervous system disorders	22.1	Systematic Assessment	EG0002 affected12 at risk EG0012 affected10 at risk EG00212 affected27 at risk EG003
Headache	Nervous system disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0012 affected10 at risk EG0021 affected27 at risk EG003
Hemiparesis	Nervous system disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Neuralgia	Nervous system disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Neuropathy peripheral	Nervous system disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0023 affected27 at risk EG003
Taste disorder	Nervous system disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0023 affected27 at risk EG003
Tremor	Nervous system disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Agitation	Psychiatric disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Anxiety	Psychiatric disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0021 affected27 at risk EG003
Delirium	Psychiatric disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Depression	Psychiatric disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Insomnia	Psychiatric disorders	22.1	Systematic Assessment	EG0003 affected12 at risk EG0012 affected10 at risk EG0020 affected27 at risk EG003
Acute kidney injury	Renal and urinary disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0023 affected27 at risk EG003
Anuria	Renal and urinary disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Dysuria	Renal and urinary disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Urinary hesitation	Renal and urinary disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0002 affected12 at risk EG0011 affected10 at risk EG0025 affected27 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0012 affected10 at risk EG0022 affected27 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0023 affected27 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0002 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0011 affected10 at risk EG0024 affected27 at risk EG003
Laryngeal inflammation	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0003 affected12 at risk EG0013 affected10 at risk EG0028 affected27 at risk EG003
Paranasal sinus hyposecretion	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Pharyngeal inflammation	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0002 affected12 at risk EG0011 affected10 at risk EG0021 affected27 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0022 affected27 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0028 affected27 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0014 affected10 at risk EG0020 affected27 at risk EG003
Dermatitis bullous	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0021 affected27 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0002 affected12 at risk EG0012 affected10 at risk EG0021 affected27 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0002 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Lichen planus	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0003 affected12 at risk EG0010 affected10 at risk EG0024 affected27 at risk EG003
Rash	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0004 affected12 at risk EG0014 affected10 at risk EG0023 affected27 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0020 affected27 at risk EG003
Skin fissures	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0012 affected10 at risk EG0020 affected27 at risk EG003
Skin reaction	Skin and subcutaneous tissue disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk EG0020 affected27 at risk EG003
Hypertension	Vascular disorders	22.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected10 at risk EG0022 affected27 at risk EG003
Hypotension	Vascular disorders	22.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003
Lymphoedema	Vascular disorders	22.1	Systematic Assessment	EG0002 affected12 at risk EG0010 affected10 at risk EG0021 affected27 at risk EG003

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
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D013812	Therapeutics

ID	Title	Description
BG000	Arm A (Cohort 1)	Nivolumab + Radiotherapy
BG001	Arm B (Cohort 1)	Cetuximab + Radiotherapy
BG002	Arm C (Cohort 2)	Cisplatin + Nivolumab + Radiotherapy
BG003	Arm D (Cohort 2)	Cisplatin + Radiotherapy
BG004	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	Arm A (Cohort 1)	Nivolumab + Radiotherapy	2	12	6	12	12	12
EG001	Arm B (Cohort 1)	Cetuximab + Radiotherapy	2	10	5	10	10	10
EG002	Arm C (Cohort 2)	Cisplatin + Nivolumab + Radiotherapy	2	27	10	27	26	27
EG003	Arm D (Cohort 2)	Cisplatin + Radiotherapy	1	24	7	24	24	24

ID	Term
D000077594	Nivolumab
D000068818	Cetuximab
D002945	Cisplatin
D011878	Radiotherapy