Open-Label Trial Of Oral PF-00299804 By Continuous Dosing... | NCT00768664

Label	Type	Description	Intervention Names
A	Experimental		Drug: PF-00299804

Name	Type	Description	Arm Group Labels	Other Names
PF-00299804	Drug	45 mg by continuous oral dosing	A

Measure	Description	Time Frame
Percentage of Participants With Objective Response (OR) of Complete Response (CR) or Partial Response (PR)	Percentage of participants with best OR of confirmed CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) relative to total number of evaluable participants for response. CR defined as disappearance of all target/non-target lesions. PR defined as at least a 30 percent (%) decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses (CR and PR) were those that persisted on a follow-up imaging assessment greater than or equal to (≥)4 weeks after the initial objective documentation of response.	Baseline up to 18 months

Measure	Description	Time Frame
Duration of Response (DR)	Time in weeks from the first documentation of objective tumor response (CR or PR) to progression or death due to progressive disease (PD). DR was calculated as (the date of the first documentation of PD or death due to PD minus the date of the first CR or PR that was subsequently confirmed plus 1). DR was calculated for the subgroup of participants with a confirmed objective tumor response (CR or PR).

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
BC Cancer Agency, Vancouver Centre		Vancouver	British Columbia	V5Z 4E6	Canada
Fairmont Medical Building

PubMed Identifier	Type	Citation	Retractions
25057165	Derived	Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Dacomitinib 45 mg	Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) received dacomitinib 45 milligram (mg) tablets, orally, once daily (QD) continuously until unacceptable toxicity, disease progression, withdrawal of consent, or death. There were no planned treatment breaks, each cycle was defined as 21 days for the purposes of scheduling. Dose reductions (in 15 mg increments) to a minimum of 15 mg QD were allowed; dose re-escalations were not allowed.

ID	Title	Description
BG000	Dacomitinib 45 mg	Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) received dacomitinib 45 milligram (mg) tablets, orally, once daily (QD) continuously until unacceptable toxicity, disease progression, withdrawal of consent, or death. There were no planned treatment breaks, each cycle was defined as 21 days for the purposes of scheduling. Dose reductions (in 15 mg increments) to a minimum of 15 mg QD were allowed; dose re-escalations were not allowed.

Units	Counts
Participants	BG00069

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Objective Response (OR) of Complete Response (CR) or Partial Response (PR)

Percentage of participants with best OR of confirmed CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) relative to total number of evaluable participants for response. CR defined as disappearance of all target/non-target lesions. PR defined as at least a 30 percent (%) decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses (CR and PR) were those that persisted on a follow-up imaging assessment greater than or equal to (≥)4 weeks after the initial objective documentation of response.

Response-Evaluable Population: All participants with measurable disease (per RECIST), treated, with baseline and ≥1 on-study assessment. Participants who discontinued early before on-study tumor assessment due to PD were evaluable, but not if discontinued early due to reasons such as participant request, lack of compliance, or early toxicity.

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline up to 18 months

ID	Title	Description
OG000	Dacomitinib 45 mg	Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) received dacomitinib 45 milligram (mg) tablets, orally, once daily (QD) continuously until unacceptable toxicity, disease progression, withdrawal of consent, or death. There were no planned treatment breaks, each cycle was defined as 21 days for the purposes of scheduling. Dose reductions (in 15 mg increments) to a minimum of 15 mg QD were allowed; dose re-escalations were not allowed.

Units	Counts
Participants	OG00063

Title

Denominators

Categories

Title	Measurements
	OG00012.5(5.6 to 23.5)

Secondary

Duration of Response (DR)

Time in weeks from the first documentation of objective tumor response (CR or PR) to progression or death due to progressive disease (PD). DR was calculated as (the date of the first documentation of PD or death due to PD minus the date of the first CR or PR that was subsequently confirmed plus 1). DR was calculated for the subgroup of participants with a confirmed objective tumor response (CR or PR).

Response Evaluable population; n equals (=) number of participants with an objective response of CR or PR.

Posted

Median

95% Confidence Interval

weeks

Baseline up to 18 months

ID	Title	Description
OG000	Dacomitinib 45 mg	Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) received dacomitinib 45 milligram (mg) tablets, orally, once daily (QD) continuously until unacceptable toxicity, disease progression, withdrawal of consent, or death. There were no planned treatment breaks, each cycle was defined as 21 days for the purposes of scheduling. Dose reductions (in 15 mg increments) to a minimum of 15 mg QD were allowed; dose re-escalations were not allowed.

Units	Counts
Participants	OG000

Secondary

Duration of Stable Disease (SD)

Time in weeks from start of treatment to date of objective disease progression (based on RECIST criteria). SD defined as neither sufficient shrinkage for PR nor sufficient increase for PD, taking as a reference the smallest sum of the longest dimensions since treatment start. Participants last known to be alive, not to have started new anticancer treatment, to be progression free, and who had a baseline and at least 1 on-study disease assessment were censored at date of last objective disease assessment that verified lack of PD. Participants who died not due to PD censored on death date.

Response Evaluable population; n=number of participants with a best overall response of SD.

Posted

Median

95% Confidence Interval

weeks

Baseline up to 18 months

ID	Title	Description
OG000	Dacomitinib 45 mg	Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) received dacomitinib 45 milligram (mg) tablets, orally, once daily (QD) continuously until unacceptable toxicity, disease progression, withdrawal of consent, or death. There were no planned treatment breaks, each cycle was defined as 21 days for the purposes of scheduling. Dose reductions (in 15 mg increments) to a minimum of 15 mg QD were allowed; dose re-escalations were not allowed.

Units	Counts
Participants

Secondary

Progression-Free Survival (PFS)

Time in weeks from date of enrollment to first documentation of PD, death due to any cause, symptomatic deterioration, or start of secondary anticancer therapy, whichever occurred first. PFS calculated as (first event date minus enrollment date plus 1). Documentation of progression determined from objective disease assessment based on RECIST criteria. PD defined as at least a 20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since treatment started or the appearance of 1 or more new lesions.

ITT Population: all enrolled participants.

Posted

Median

95% Confidence Interval

weeks

Baseline up to 18 months

ID	Title	Description
OG000	Dacomitinib 45 mg	Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) received dacomitinib 45 milligram (mg) tablets, orally, once daily (QD) continuously until unacceptable toxicity, disease progression, withdrawal of consent, or death. There were no planned treatment breaks, each cycle was defined as 21 days for the purposes of scheduling. Dose reductions (in 15 mg increments) to a minimum of 15 mg QD were allowed; dose re-escalations were not allowed.

Units	Counts
Participants

Secondary

Progression-Free Survival (PFS) at 6 Months and at 1 Year

Probability of being event-free (event defined as PD, death due to any cause, symptomatic deterioration, or start of secondary anticancer therapy) at 26 weeks and 52 weeks after the first dose of study treatment.

ITT Population

Posted

Number

95% Confidence Interval

percent chance of being event free

Baseline up to 52 weeks

ID	Title	Description
OG000	Dacomitinib 45 mg	Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) received dacomitinib 45 milligram (mg) tablets, orally, once daily (QD) continuously until unacceptable toxicity, disease progression, withdrawal of consent, or death. There were no planned treatment breaks, each cycle was defined as 21 days for the purposes of scheduling. Dose reductions (in 15 mg increments) to a minimum of 15 mg QD were allowed; dose re-escalations were not allowed.

Units	Counts
Participants	OG000

Secondary

Overall Survival (OS)

Time in weeks from the start date of enrollment to date of death due to any cause. OS was calculated as (the death date minus the enrollment date plus 1). Participants without death dates, last known to be alive were censored at last contact.

ITT Population

Posted

Median

95% Confidence Interval

weeks

Baseline up to 18 months

ID	Title	Description
OG000	Dacomitinib 45 mg	Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) received dacomitinib 45 milligram (mg) tablets, orally, once daily (QD) continuously until unacceptable toxicity, disease progression, withdrawal of consent, or death. There were no planned treatment breaks, each cycle was defined as 21 days for the purposes of scheduling. Dose reductions (in 15 mg increments) to a minimum of 15 mg QD were allowed; dose re-escalations were not allowed.

Units	Counts
Participants	OG000

Secondary

Overall Survival at 6 Months and 1 Year

Probability of survival 26 weeks and 52 weeks after the first dose of study treatment.

ITT Population

Posted

Number

95% Confidence Interval

percent chance of survival

Baseline up to Week 52

ID	Title	Description
OG000	Dacomitinib 45 mg	Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) received dacomitinib 45 milligram (mg) tablets, orally, once daily (QD) continuously until unacceptable toxicity, disease progression, withdrawal of consent, or death. There were no planned treatment breaks, each cycle was defined as 21 days for the purposes of scheduling. Dose reductions (in 15 mg increments) to a minimum of 15 mg QD were allowed; dose re-escalations were not allowed.

Units	Counts
Participants	OG000

Secondary

Trough Plasma Concentrations (Ctrough) of Dacomitinib After Repeat Dosing

Trough concentrations of dacomitinib in plasma measured as nanograms per milliliter (ng/mL).

Pharmacokinetic (PK) population: all enrolled participants who received at least 1 dose of study medication from whom at least 1 PK sample was obtained. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for specific rows.

Posted

Median

Full Range

ng/mL

Predose on Day 1 of Cycles 2, 3, and 4 and predose on Day 8 of Cycle 1

ID	Title	Description
OG000	Dacomitinib 45 mg	Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) received dacomitinib 45 milligram (mg) tablets, orally, once daily (QD) continuously until unacceptable toxicity, disease progression, withdrawal of consent, or death. There were no planned treatment breaks, each cycle was defined as 21 days for the purposes of scheduling. Dose reductions (in 15 mg increments) to a minimum of 15 mg QD were allowed; dose re-escalations were not allowed.

Units	Counts
Participants	OG000

Secondary

Ctrough of Dacomitinib After Repeat Dosing In Participants Requiring Administration of Dacomitinib With a Feeding Tube

PK population: all enrolled participants who received at least 1 dose of study medication from whom at least 1 PK sample was obtained. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for specific rows.

Posted

Median

Full Range

ng/mL

Predose on Day 1 of Cycles 2, 3, and 4 and predose on Day 8 of Cycle 1

ID	Title	Description
OG000	Dacomitinib 45 mg	Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) received dacomitinib 45 milligram (mg) tablets, orally, once daily (QD) continuously until unacceptable toxicity, disease progression, withdrawal of consent, or death. There were no planned treatment breaks, each cycle was defined as 21 days for the purposes of scheduling. Dose reductions (in 15 mg increments) to a minimum of 15 mg QD were allowed; dose re-escalations were not allowed.

Units	Counts
Participants	OG000

Secondary

Maximum Observed Plasma Concentration (Cmax) In Participants Requiring Administration of Dacomitinib With a Feeding Tube

PK Population; n=number of participants requiring administration of dacomitinib with a feeding tube.

Posted

Median

Full Range

ng/mL

Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose

ID	Title	Description
OG000	Dacomitinib 45 mg	Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) received dacomitinib 45 milligram (mg) tablets, orally, once daily (QD) continuously until unacceptable toxicity, disease progression, withdrawal of consent, or death. There were no planned treatment breaks, each cycle was defined as 21 days for the purposes of scheduling. Dose reductions (in 15 mg increments) to a minimum of 15 mg QD were allowed; dose re-escalations were not allowed.

Units	Counts
Participants	OG000

Secondary

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) In Participants Requiring Administration of Dacomitinib With a Feeding Tube

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).

PK Population; n=number of participants requiring administration of dacomitinib with a feeding tube.

Posted

Median

Full Range

ng*hour (hr)/mL

Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose

ID	Title	Description
OG000	Dacomitinib 45 mg	Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) received dacomitinib 45 milligram (mg) tablets, orally, once daily (QD) continuously until unacceptable toxicity, disease progression, withdrawal of consent, or death. There were no planned treatment breaks, each cycle was defined as 21 days for the purposes of scheduling. Dose reductions (in 15 mg increments) to a minimum of 15 mg QD were allowed; dose re-escalations were not allowed.

Units	Counts
Participants	OG000

Secondary

Time to Reach Maximum Observed Plasma Concentration (Tmax) In Participants Requiring Administration of Dacomitinib With a Feeding Tube

PK Population; n=number of participants requiring administration of dacomitinib with a feeding tube.

Posted

Median

Full Range

hours

Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose

ID	Title	Description
OG000	Dacomitinib 45 mg	Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) received dacomitinib 45 milligram (mg) tablets, orally, once daily (QD) continuously until unacceptable toxicity, disease progression, withdrawal of consent, or death. There were no planned treatment breaks, each cycle was defined as 21 days for the purposes of scheduling. Dose reductions (in 15 mg increments) to a minimum of 15 mg QD were allowed; dose re-escalations were not allowed.

Units	Counts
Participants	OG000

Secondary

Plasma Decay Half-Life (t1/2)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

PK Population; n=number of participants requiring administration of dacomitinib with a feeding tube.

Posted

Median

Full Range

hours

Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose

ID	Title	Description
OG000	Dacomitinib 45 mg	Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) received dacomitinib 45 milligram (mg) tablets, orally, once daily (QD) continuously until unacceptable toxicity, disease progression, withdrawal of consent, or death. There were no planned treatment breaks, each cycle was defined as 21 days for the purposes of scheduling. Dose reductions (in 15 mg increments) to a minimum of 15 mg QD were allowed; dose re-escalations were not allowed.

Units	Counts
Participants	OG000

Secondary

Correlation Between Biomarkers Status and Best Overall Response

The best overall response was best response recorded from the start of the treatment until disease progression/recurrence. In this outcome measure, biomarkers status and best overall response was reported in terms of correlation coefficient.

Biomarker analysis set: all enrolled participants who had baseline samples submitted as per Institutional Review Board/Independent Ethics Committee approval and participant consent. Here, "number analyzed" signifies participants evaluable at specific rows.

Posted

Number

Correlation coefficient

Baseline up to 18 months

ID	Title	Description
OG000	Dacomitinib 45 mg	Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) received dacomitinib 45 milligram (mg) tablets, orally, once daily (QD) continuously until unacceptable toxicity, disease progression, withdrawal of consent, or death. There were no planned treatment breaks, each cycle was defined as 21 days for the purposes of scheduling. Dose reductions (in 15 mg increments) to a minimum of 15 mg QD were allowed; dose re-escalations were not allowed.

Units	Counts
Participants

Secondary

H-Score at Baseline and Post-baseline for Paired Biopsy Biomarkers

H-score is a measure of the immunohistochemistry staining positivity. The range for H-score is between 0 and 300. A higher score refers to stronger staining of a particular marker.

Biomarker analysis set: all enrolled participants who had baseline samples submitted as per Institutional Review Board/Independent Ethics Committee approval and participant consent. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measures and "number analyzed" signifies participants evaluable at specific rows.

Posted

Mean

Standard Deviation

Score on a scale

Baseline up to 18 Months

ID	Title	Description
OG000	Dacomitinib 45 mg	Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) received dacomitinib 45 milligram (mg) tablets, orally, once daily (QD) continuously until unacceptable toxicity, disease progression, withdrawal of consent, or death. There were no planned treatment breaks, each cycle was defined as 21 days for the purposes of scheduling. Dose reductions (in 15 mg increments) to a minimum of 15 mg QD were allowed; dose re-escalations were not allowed.

Units	Counts
Participants

Secondary

H-Score at Ratio to Baseline for Paired Biopsy Biomarkers

H-score is a measure of the immunohistochemistry staining positivity. The range for H-score is between 0 and 300. A higher score refers to stronger staining of a particular marker.

Biomarker analysis set: all enrolled participants who had baseline samples submitted as per Institutional Review Board/Independent Ethics Committee approval and participant consent. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measures and "number analyzed" signifies participants evaluable at specific rows.

Posted

Mean

Standard Deviation

Ratio

Baseline up to 18 Months

ID	Title	Description
OG000	Dacomitinib 45 mg	Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) received dacomitinib 45 milligram (mg) tablets, orally, once daily (QD) continuously until unacceptable toxicity, disease progression, withdrawal of consent, or death. There were no planned treatment breaks, each cycle was defined as 21 days for the purposes of scheduling. Dose reductions (in 15 mg increments) to a minimum of 15 mg QD were allowed; dose re-escalations were not allowed.

Units	Counts
Participants

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Atrial flutter	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Pericardial effusion	Cardiac disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Deafness	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected69 at risk
Hearing impaired	Ear and labyrinth disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Hypothyroidism	Endocrine disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected69 at risk
Blepharitis	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected69 at risk
Conjunctival irritation	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Conjunctivitis	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected69 at risk
Dry eye	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Entropion	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Eye discharge	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Eye irritation	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Eye oedema	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Eye pain	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Eye pruritus	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Eyelids pruritus	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Lacrimation increased	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Ocular hyperaemia	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Vision blurred	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected69 at risk
Visual impairment	Eye disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected69 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Anorectal disorder	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Aptyalism	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Cheilitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected69 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected69 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00058 affected69 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected69 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected69 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected69 at risk
Eructation	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Flatulence	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Gingival pain	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Glossodynia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected69 at risk
Lip dry	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Lip haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Lip pain	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00015 affected69 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Oral pain	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected69 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Proctitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Saliva altered	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00023 affected69 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00010 affected69 at risk
Adverse drug reaction	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Asthenia	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Chest pain	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected69 at risk
Chills	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected69 at risk
Face oedema	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected69 at risk
Fatigue	General disorders	MedDRA 14.0	Non-systematic Assessment	EG00035 affected69 at risk
Influenza like illness	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Irritability	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Local swelling	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Mucosal inflammation	General disorders	MedDRA 14.0	Non-systematic Assessment	EG00011 affected69 at risk
Oedema peripheral	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected69 at risk
Performance status decreased	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Pyrexia	General disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected69 at risk
Candidiasis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0003 affected69 at risk
Cystitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Fungal infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Groin infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Localised infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Nasopharyngitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Oral candidiasis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Otitis media	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Paronychia	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG00012 affected69 at risk
Pneumonia	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0003 affected69 at risk
Rhinitis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0006 affected69 at risk
Skin infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Tinea pedis	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Eye penetration	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Procedural site reaction	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Radiation skin injury	Injury, poisoning and procedural complications	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Alanine aminotransferase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Blood creatinine increased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Haemoglobin decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Weight decreased	Investigations	MedDRA 14.0	Non-systematic Assessment	EG00012 affected69 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG00018 affected69 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected69 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected69 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected69 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected69 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected69 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Hypercreatinaemia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Infected neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Non-systematic Assessment	EG0004 affected69 at risk
Cognitive disorder	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Dizziness	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected69 at risk
Dysgeusia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Headache	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected69 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected69 at risk
Motor dysfunction	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected69 at risk
Paraesthesia	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Sinus headache	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Somnolence	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Anxiety	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Confusional state	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Depressed mood	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Insomnia	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0007 affected69 at risk
Libido decreased	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Mood altered	Psychiatric disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Proteinuria	Renal and urinary disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00013 affected69 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected69 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0008 affected69 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG00010 affected69 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected69 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Pharyngeal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Rhinalgia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0009 affected69 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected69 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG00052 affected69 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG00034 affected69 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected69 at risk
Exfoliative rash	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG00017 affected69 at risk
Granuloma skin	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Hair colour changes	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Hair growth abnormal	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Nail bed inflammation	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0006 affected69 at risk
Onychomadesis	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected69 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG00024 affected69 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG00020 affected69 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG00011 affected69 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected69 at risk
Scab	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Skin chapped	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0004 affected69 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0005 affected69 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0002 affected69 at risk
Telangiectasia	Skin and subcutaneous tissue disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Flushing	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Haemorrhage	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Hypertension	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0003 affected69 at risk
Hypotension	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Intra-abdominal haematoma	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Lymphoedema	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk
Thrombosis	Vascular disorders	MedDRA 14.0	Non-systematic Assessment	EG0001 affected69 at risk

ID	Term
D006258	Head and Neck Neoplasms
D012008	Recurrence

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