Trial Outcomes & Findings for Gabapentin, Methadone, and Oxycodone With or Without Venlafaxine Hydrochloride in Managing Pain in Participants With Stage II-IV Squamous Cell Head and Neck Cancer Undergoing Chemoradiation Therapy (NCT NCT03574792)

Last Updated: 2026-04-16

Results Overview

To assess the pain-reduction effects of adding venlafaxine to a regimen of gabapentin and methadone to control pain during and after chemoradiation, per European Organization for Research and Treatment of Cancer (EORTC) Head and Neck Cancer Module (EORTC QLQ-H and N35). The pain scores range between 0 and 100, with higher values represent worse outcomes. The pain scores (mean/standard deviation) of baseline and end of treatment (week 7) are reported.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

62 participants

Primary outcome timeframe

Participants were assessed up to 24 months after enrollment, change in score from baseline at week 7 reported

Results posted on

2026-04-16

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Gabapentin, Methadone, Oxycodone) Participants receive gabapentin PO daily or TID. Participants may also receive methadone PO TID and oxycodone PO every 8 hours as needed. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Gabapentin: Given PO Methadone: Given PO Oxycodone: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Arm II (Gabapentin, Methadone, Oxycodone, Venlafaxine) Participants receive gabapentin, methadone, and oxycodone as in Arm I and venlafaxine PO BID or venlafaxine hydrochloride extended release daily for up to 12 months in the absence of disease progression or unacceptable toxicity. Gabapentin: Given PO Methadone: Given PO Oxycodone: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Venlafaxine: Given PO Venlafaxine Hydrochloride Extended Release: Given PO
Overall Study NOT COMPLETED	0	0
Overall Study STARTED	32	30
Overall Study COMPLETED	32	30

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gabapentin, Methadone, and Oxycodone With or Without Venlafaxine Hydrochloride in Managing Pain in Participants With Stage II-IV Squamous Cell Head and Neck Cancer Undergoing Chemoradiation Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Gabapentin, Methadone, Oxycodone) n=32 Participants Participants receive gabapentin PO daily or TID. Participants may also receive methadone PO TID and oxycodone PO every 8 hours as needed. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Gabapentin: Given PO Methadone: Given PO Oxycodone: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Arm II (Gabapentin, Methadone, Oxycodone, Venlafaxine) n=30 Participants Participants receive gabapentin, methadone, and oxycodone as in Arm I and venlafaxine PO BID or venlafaxine hydrochloride extended release daily for up to 12 months in the absence of disease progression or unacceptable toxicity. Gabapentin: Given PO Methadone: Given PO Oxycodone: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Venlafaxine: Given PO Venlafaxine Hydrochloride Extended Release: Given PO	Total n=62 Participants Total of all reporting groups
Race (NIH/OMB) Black or African American	1 Participants n=193 Participants	1 Participants n=193 Participants	2 Participants n=386 Participants
Race (NIH/OMB) White	31 Participants n=193 Participants	27 Participants n=193 Participants	58 Participants n=386 Participants
Race (NIH/OMB) More than one race	0 Participants n=193 Participants	0 Participants n=193 Participants	0 Participants n=386 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=193 Participants	2 Participants n=193 Participants	2 Participants n=386 Participants
Age, Categorical <=18 years	0 Participants n=193 Participants	0 Participants n=193 Participants	0 Participants n=386 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=193 Participants	23 Participants n=193 Participants	40 Participants n=386 Participants
Age, Categorical >=65 years	15 Participants n=193 Participants	7 Participants n=193 Participants	22 Participants n=386 Participants
Age, Continuous	63 years n=193 Participants	59 years n=193 Participants	60 years n=386 Participants
Sex: Female, Male Female	4 Participants n=193 Participants	3 Participants n=193 Participants	7 Participants n=386 Participants
Sex: Female, Male Male	28 Participants n=193 Participants	27 Participants n=193 Participants	55 Participants n=386 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=193 Participants	0 Participants n=193 Participants	0 Participants n=386 Participants
Race (NIH/OMB) Asian	0 Participants n=193 Participants	0 Participants n=193 Participants	0 Participants n=386 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=193 Participants	0 Participants n=193 Participants	0 Participants n=386 Participants

PRIMARY outcome

Timeframe: Participants were assessed up to 24 months after enrollment, change in score from baseline at week 7 reported

Outcome measures

Outcome measures
Measure	Arm I (Gabapentin, Methadone, Oxycodone) n=32 Participants Participants receive gabapentin PO daily or TID. Participants may also receive methadone PO TID and oxycodone PO every 8 hours as needed. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Gabapentin: Given PO Methadone: Given PO Oxycodone: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Arm II (Gabapentin, Methadone, Oxycodone, Venlafaxine) n=30 Participants Participants receive gabapentin, methadone, and oxycodone as in Arm I and venlafaxine PO BID or venlafaxine hydrochloride extended release daily for up to 12 months in the absence of disease progression or unacceptable toxicity. Gabapentin: Given PO Methadone: Given PO Oxycodone: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Venlafaxine: Given PO Venlafaxine Hydrochloride Extended Release: Given PO
Pain-reduction Effects of Adding Venlafaxine to a Regimen of Gabapentin and Methadone to Control Pain During and After Chemoradiation Baseline	8 scores on a scale Standard Deviation 10	13 scores on a scale Standard Deviation 17
Pain-reduction Effects of Adding Venlafaxine to a Regimen of Gabapentin and Methadone to Control Pain During and After Chemoradiation End of treatment (week 7)	39 scores on a scale Standard Deviation 20	40 scores on a scale Standard Deviation 20

SECONDARY outcome

Timeframe: Up to 24 months

Toxicities will be tabulated by treatment arm using the maximum grade observed by participant. Possible differences by treatment will be described using odds ratio and 95% confidence interval estimates derived use Mantel?Haenszel methods to account for laterality of the radiation treatment.

Outcome measures

Outcome measures
Measure	Arm I (Gabapentin, Methadone, Oxycodone) n=32 Participants Participants receive gabapentin PO daily or TID. Participants may also receive methadone PO TID and oxycodone PO every 8 hours as needed. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Gabapentin: Given PO Methadone: Given PO Oxycodone: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Arm II (Gabapentin, Methadone, Oxycodone, Venlafaxine) n=30 Participants Participants receive gabapentin, methadone, and oxycodone as in Arm I and venlafaxine PO BID or venlafaxine hydrochloride extended release daily for up to 12 months in the absence of disease progression or unacceptable toxicity. Gabapentin: Given PO Methadone: Given PO Oxycodone: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Venlafaxine: Given PO Venlafaxine Hydrochloride Extended Release: Given PO
Incidence of Adverse Events of Pain Regimen Per Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 4.0) SAE AEs	9 participants	6 participants
Incidence of Adverse Events of Pain Regimen Per Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 4.0) NON-SAE AEs	22 participants	24 participants

Adverse Events

Arm I (Gabapentin, Methadone, Oxycodone)

Serious events: 9 serious events

Other events: 22 other events

Deaths: 0 deaths

Arm II (Gabapentin, Methadone, Oxycodone, Venlafaxine)

Serious events: 6 serious events

Other events: 24 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Katy Wang, MA. Biostatistican

Roswell Park Cancer Comprehensive Center

Phone: 7168451300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm I (Gabapentin, Methadone, Oxycodone) n=32 participants at risk Participants receive gabapentin PO daily or TID. Participants may also receive methadone PO TID and oxycodone PO every 8 hours as needed. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Gabapentin: Given PO Methadone: Given PO Oxycodone: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Arm II (Gabapentin, Methadone, Oxycodone, Venlafaxine) n=30 participants at risk Participants receive gabapentin, methadone, and oxycodone as in Arm I and venlafaxine PO BID or venlafaxine hydrochloride extended release daily for up to 12 months in the absence of disease progression or unacceptable toxicity. Gabapentin: Given PO Methadone: Given PO Oxycodone: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Venlafaxine: Given PO Venlafaxine Hydrochloride Extended Release: Given PO
Blood and lymphatic system disorders Anaemia	0.00% 0/32 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	3.3% 1/30 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Gastrointestinal disorders Gastrointestinal haemorrhage	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	0.00% 0/30 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Gastrointestinal disorders Nausea	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	0.00% 0/30 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
General disorders Pyrexia	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	0.00% 0/30 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Infections and infestations Cellulitis	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	0.00% 0/30 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Infections and infestations Diverticulitis	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	0.00% 0/30 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Infections and infestations Peritonitis	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	0.00% 0/30 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Metabolism and nutrition disorders Dehydration	9.4% 3/32 • Number of events 3 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	6.7% 2/30 • Number of events 2 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Metabolism and nutrition disorders Failure to thrive	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	3.3% 1/30 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Nervous system disorders Dizziness	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	0.00% 0/30 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Renal and urinary disorders Acute kidney injury	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	3.3% 1/30 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Respiratory, thoracic and mediastinal disorders Aspiration	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	0.00% 0/30 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	0.00% 0/30 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/32 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	6.7% 2/30 • Number of events 2 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Vascular disorders Embolism	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	0.00% 0/30 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months

Measure	Arm I (Gabapentin, Methadone, Oxycodone) n=32 participants at risk Participants receive gabapentin PO daily or TID. Participants may also receive methadone PO TID and oxycodone PO every 8 hours as needed. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Gabapentin: Given PO Methadone: Given PO Oxycodone: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies	Arm II (Gabapentin, Methadone, Oxycodone, Venlafaxine) n=30 participants at risk Participants receive gabapentin, methadone, and oxycodone as in Arm I and venlafaxine PO BID or venlafaxine hydrochloride extended release daily for up to 12 months in the absence of disease progression or unacceptable toxicity. Gabapentin: Given PO Methadone: Given PO Oxycodone: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Venlafaxine: Given PO Venlafaxine Hydrochloride Extended Release: Given PO
Gastrointestinal disorders Stomatitis	0.00% 0/32 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	6.7% 2/30 • Number of events 2 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Gastrointestinal disorders Vomiting	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	0.00% 0/30 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
General disorders Fatigue	0.00% 0/32 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	6.7% 2/30 • Number of events 2 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
General disorders Mucosal disorder	9.4% 3/32 • Number of events 3 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	3.3% 1/30 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
General disorders Mucosal inflammation	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	6.7% 2/30 • Number of events 2 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
General disorders Pain	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	10.0% 3/30 • Number of events 3 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Metabolism and nutrition disorders Decreased appetite	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	3.3% 1/30 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/32 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	3.3% 1/30 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	0.00% 0/30 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Musculoskeletal and connective tissue disorders Pain in jaw	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	0.00% 0/30 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Nervous system disorders Balance disorder	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	0.00% 0/30 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Nervous system disorders Dizziness	0.00% 0/32 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	3.3% 1/30 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Nervous system disorders Headache	0.00% 0/32 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	3.3% 1/30 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Nervous system disorders Hypoaesthesia	0.00% 0/32 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	3.3% 1/30 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Nervous system disorders Mental impairment	0.00% 0/32 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	3.3% 1/30 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Psychiatric disorders Anxiety	0.00% 0/32 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	3.3% 1/30 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Psychiatric disorders Depression	0.00% 0/32 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	3.3% 1/30 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Psychiatric disorders Insomnia	0.00% 0/32 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	3.3% 1/30 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Renal and urinary disorders Incontinence	0.00% 0/32 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	3.3% 1/30 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Respiratory, thoracic and mediastinal disorders Dysphonia	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	0.00% 0/30 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.2% 2/32 • Number of events 2 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	0.00% 0/30 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Respiratory, thoracic and mediastinal disorders Throat irritation	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	0.00% 0/30 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Skin and subcutaneous tissue disorders Skin exfoliation	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	3.3% 1/30 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Gastrointestinal disorders Diarrhoea	0.00% 0/32 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	3.3% 1/30 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Gastrointestinal disorders Dysphagia	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	3.3% 1/30 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Gastrointestinal disorders Nausea	3.1% 1/32 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	3.3% 1/30 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Gastrointestinal disorders Odynophagia	43.8% 14/32 • Number of events 16 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	56.7% 17/30 • Number of events 22 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Gastrointestinal disorders Oesophageal pain	0.00% 0/32 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	3.3% 1/30 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months
Gastrointestinal disorders Oesophagitis	0.00% 0/32 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months	3.3% 1/30 • Number of events 1 • Health-related quality of life surveys were performed at baseline, the end of chemoradiation, and at subsequent follow-up visits occurring at 4 weeks, 3 months, and 6 months with optional follow-up at 9 and 12 and 24 months