Trial Outcomes & Findings for Phase II Treatment Stratification Trial Using Neck Dissection-Driven Selection to Improve Quality of Life for Low Risk Patients With HPV+ Oropharyngeal Squamous Cell Cancer (NCT NCT02784288)

Last Updated: 2023-06-27

Results Overview

Four QOL instruments will be administered: the University of Washington Quality of Life (UWQOL), University of Michigan Head and Neck Quality of Life Instrument (HN-QOL), the University of Michigan Voice Related Quality of Life Measure (V-RQOL), and the FACT Head and Neck (version 4) (FACT H\&N). Results of each of the 4 surveys will be reported in separate rows in the results table. The difference in scores from baseline to 12 months after completion of study treatment is calculated for each participant, with the median across all participants reported for each survey. Higher scores indicate better QOLs. Range for Questionnaires: HN QOLs: -100 to +100 VR QOLs: -100 to +100 UW QOLs: -100 to +100 FACTHN Physical: -28 to +28 FACTHN Social: -28 to +28 FACTHN Emotional: -24 to +24 FACTHN Functional: -28 to +28 FACTHN subscale: -40 to +40 FACTHN Total: -148 to +148

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Baseline to 12 Months post-treatment (up to approximately 15 months post neck dissection).

Results posted on

2023-06-27

Participant Flow

40 patients consented only 34 enrolled and started on treatment

Participant milestones

Participant milestones
Measure	Neck Dissection Patients undergo up-front neck dissection of the cervical lymph nodes to determine stratification into one of three standard-of-care treatment groups: transoral surgery of the primary site, radiation or chemoradiation. Neck Dissection: All patients will undergo neck dissection of the cervical lymph nodes Standard-of-Care (SOC) Transoral Surgery of Primary Site: Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site. SOC Radiation: Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation. SOC Carboplatin: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). SOC Paclitaxel: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). Videofluoroscopy: All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function.
Overall Study STARTED	34
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Neck Dissection Patients undergo up-front neck dissection of the cervical lymph nodes to determine stratification into one of three standard-of-care treatment groups: transoral surgery of the primary site, radiation or chemoradiation. Neck Dissection: All patients will undergo neck dissection of the cervical lymph nodes Standard-of-Care (SOC) Transoral Surgery of Primary Site: Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site. SOC Radiation: Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation. SOC Carboplatin: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). SOC Paclitaxel: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). Videofluoroscopy: All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function.
Overall Study Patients neck dissection had spillage and therefore needed to come off protocol	1

Baseline Characteristics

Phase II Treatment Stratification Trial Using Neck Dissection-Driven Selection to Improve Quality of Life for Low Risk Patients With HPV+ Oropharyngeal Squamous Cell Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neck Dissection n=34 Participants Patients undergo up-front neck dissection of the cervical lymph nodes to determine stratification into one of three standard-of-care treatment groups: transoral surgery of the primary site, radiation or chemoradiation. Neck Dissection: All patients will undergo neck dissection of the cervical lymph nodes Standard-of-Care (SOC) Transoral Surgery of Primary Site: Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site. SOC Radiation: Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation. SOC Carboplatin: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). SOC Paclitaxel: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). Videofluoroscopy: All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function.
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 12 Months post-treatment (up to approximately 15 months post neck dissection).

Population: only 19 patients, out of 34, were compliant in completing the 12 month QOLs.

Outcome measures

Outcome measures
Measure	Neck Dissection n=19 Participants Patients undergo up-front neck dissection of the cervical lymph nodes to determine stratification into one of three standard-of-care treatment groups: transoral surgery of the primary site, radiation or chemoradiation. Neck Dissection: All patients will undergo neck dissection of the cervical lymph nodes Standard-of-Care (SOC) Transoral Surgery of Primary Site: Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site. SOC Radiation: Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation. SOC Carboplatin: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). SOC Paclitaxel: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). Videofluoroscopy: All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function.
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment HN-QOL: Eating	-4.2 score on a scale Interval -37.5 to 29.2
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment HN-QOL: Speech	0 score on a scale Interval -37.5 to 25.0
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment HN-QOL: Pain	6.3 score on a scale Interval -18.8 to 37.5
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment HN-QOL: Emotion	10.7 score on a scale Interval -3.6 to 25.0
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment UW-QOL: Pain_general	0 score on a scale Interval -40.0 to 0.0
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment UW-QOL: Pain_mouth	0 score on a scale Interval -30.0 to 10.0
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment UW-QOL: Pain_throat	-10 score on a scale Interval -20.0 to 10.0
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment UW-QOL: Disfigurement	0 score on a scale Interval -10.0 to 20.0
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment UW-QOL: Activity	0 score on a scale Interval -10.0 to 10.0
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment UW-QOL: Recreation	0 score on a scale Interval -10.0 to 10.0
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment UW-QOL: Employment	0 score on a scale Interval 0.0 to 20.0
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment UW-QOL: Chewing	0 score on a scale Interval -20.0 to 10.0
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment UW-QOL: Swallowing	0 score on a scale Interval -30.0 to 10.0
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment UW-QOL: Saliva amount	10 score on a scale Interval 0.0 to 40.0
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment UW-QOL: Saliva consistency	0 score on a scale Interval -20.0 to 10.0
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment UW-QOL: Taste	10 score on a scale Interval -10.0 to 30.0
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment UW-QOL: Speech	0 score on a scale Interval -10.0 to 10.0
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment UW-QOL: Mucus amount	0 score on a scale Interval -30.0 to 20.0
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment UW-QOL: Mucus consistency	0 score on a scale Interval -20.0 to 20.0
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment V-RQOL: Physical	0 score on a scale Interval -0.2 to 0.04
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment V-RQOL: Emotional	0 score on a scale Interval -0.06 to 0.0
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment V-RQOL: Total	0 score on a scale Interval -0.1 to 0.03
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment FACT H&N: Physical Well Being	1 score on a scale Interval -6.0 to 7.0
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment FACT H&N: Social Well Being	0 score on a scale Interval -7.5 to 5.0
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment FACT H&N: Emotional Well Being	3 score on a scale Interval -4.0 to 6.0
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment FACT H&N: Functional Well Being	0 score on a scale Interval -9.0 to 7.0
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment FACT H&N: HN subscale	-1 score on a scale Interval -12.0 to 12.0
Median Change in Quality of Life (QOL) From Baseline to 12 Months Post Treatment FACT H&N: Total	4 score on a scale Interval -21.0 to 19.0

SECONDARY outcome

Timeframe: 2 years post-treatment (up to approximately 27 months post neck dissection)

The neck dissection impairment index will be scored and summarized for all patients who receive neck dissection. Scores ranging from 0-100 with higher scores indicating better function

Outcome measures

Outcome measures
Measure	Neck Dissection n=20 Participants Patients undergo up-front neck dissection of the cervical lymph nodes to determine stratification into one of three standard-of-care treatment groups: transoral surgery of the primary site, radiation or chemoradiation. Neck Dissection: All patients will undergo neck dissection of the cervical lymph nodes Standard-of-Care (SOC) Transoral Surgery of Primary Site: Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site. SOC Radiation: Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation. SOC Carboplatin: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). SOC Paclitaxel: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). Videofluoroscopy: All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function.
Impact of Neck Dissection on Shoulder Function Using the Neck Dissection Impairment Index	98 score on a scale Interval 78.0 to 100.0

SECONDARY outcome

Timeframe: 2 years post-treatment (up to approximately 27 months post neck dissection)

Population: only 19 patients, out of 34, were compliant in completing the 24 month QOLs

Four QOL instruments will be administered: the University of Washington Quality of Life (UWQOL), University of Michigan Head and Neck Quality of Life Instrument (HN-QOL), the University of Michigan Voice Related Quality of Life Measure (V-RQOL), and the FACT Head and Neck (version 4) (FACT H\&N). Results of each of the 4 surveys will be reported in separate rows in the results table. The difference in scores from baseline to 24 months after completion of study treatment is calculated for each participant, with the median across all participants reported for each survey. Higher scores indicate better QOLs. Range for Questionnaires: HN QOLs: -100 to +100 VR QOLs: -100 to +100 UW QOLs: -100 to +100 FACTHN Physical: -28 to +28 FACTHN Social: -28 to +28 FACTHN Emotional: -24 to +24 FACTHN Functional: -28 to +28 FACTHN subscale: -40 to +40 FACTHN Total: -148 to +148

Outcome measures

Outcome measures
Measure	Neck Dissection n=19 Participants Patients undergo up-front neck dissection of the cervical lymph nodes to determine stratification into one of three standard-of-care treatment groups: transoral surgery of the primary site, radiation or chemoradiation. Neck Dissection: All patients will undergo neck dissection of the cervical lymph nodes Standard-of-Care (SOC) Transoral Surgery of Primary Site: Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site. SOC Radiation: Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation. SOC Carboplatin: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). SOC Paclitaxel: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). Videofluoroscopy: All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function.
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment UWQOL- Disfigurement	0 score on a scale Interval -10.0 to 20.0
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment V-RQOL- Emotional	0 score on a scale Interval -0.3 to 0.0
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment FACT H&N- total FACTHN	1 score on a scale Interval -20.0 to 31.3
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment UWQOL- Pain_Mouth	0 score on a scale Interval -20.0 to 10.0
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment UWQOL-Pain_General	-10 score on a scale Interval -30.0 to 10.0
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment HN-QOL- Eating	0.0 score on a scale Interval -41.7 to 29.2
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment UWQOL- Pain_throat	-10 score on a scale Interval -20.0 to 10.0
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment HN-QOL- Speech	0.0 score on a scale Interval -12.5 to 25.0
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment HN-QOL- Pain	6.3 score on a scale Interval -18.8 to 31.3
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment HN-QOL- Emotion	10.7 score on a scale Interval -3.6 to 28.6
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment UWQOL- activity	0 score on a scale Interval -10.0 to 10.0
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment UWQOL-Recreation	0 score on a scale Interval -10.0 to 10.0
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment UWQOL- Employment	0 score on a scale Interval -30.0 to 40.0
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment UWQOL- Chewing	0 score on a scale Interval -20.0 to 30.0
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment UWQOL- Swallowing	0 score on a scale Interval -40.0 to 10.0
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment UWQOL- Saliva amount	10 score on a scale Interval 0.0 to 40.0
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment UWQOL- Saliva consistency	0 score on a scale Interval -10.0 to 40.0
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment UWQOL- Taste	0 score on a scale Interval -30.0 to 20.0
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment UWQOL- Speech	0 score on a scale Interval -10.0 to 20.0
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment UWQOL- Mucus amount	0 score on a scale Interval -40.0 to 20.0
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment UWQOL- Mucus consistency	0 score on a scale Interval -40.0 to 20.0
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment V-RQOL- Physical	0 score on a scale Interval -0.1 to 0.1
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment V-RQOL- Total	0 score on a scale Interval -0.2 to 0.06
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment FACT H&N- Physical well being	0 score on a scale Interval -6.0 to 6.0
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment FACT H&N- Social well being	0 score on a scale Interval -8.5 to 9.3
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment FACT H&N- Emotional well being	2 score on a scale Interval -4.0 to 5.0
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment FACT H&N- Functional well being	0 score on a scale Interval -7.0 to 11.0
Median Change in Quality of Life (QOL) From Baseline to 24 Months Post Treatment FACT H&N- HN subscale	2 score on a scale Interval -17.0 to 11.0

SECONDARY outcome

Timeframe: 3 Years

Proportion of patients alive at 3 years from date of neck dissection. Death from OPSCC (Oropharyngeal Squamous Cell Cancer) will be considered an event for DSS. Death from other causes will be censored at time of death.

Outcome measures

Outcome measures
Measure	Neck Dissection n=33 Participants Patients undergo up-front neck dissection of the cervical lymph nodes to determine stratification into one of three standard-of-care treatment groups: transoral surgery of the primary site, radiation or chemoradiation. Neck Dissection: All patients will undergo neck dissection of the cervical lymph nodes Standard-of-Care (SOC) Transoral Surgery of Primary Site: Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site. SOC Radiation: Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation. SOC Carboplatin: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). SOC Paclitaxel: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). Videofluoroscopy: All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function.
Disease Specific Survival (DSS)	100 percentage of participants

SECONDARY outcome

Timeframe: 3 Years

Proportion of patients alive and free of disease persistence, progression or recurrence at 3 years from the date of completion of study treatment. Persistent disease at completion of treatment, post-treatment recurrence or disease specific death will be defined events for progression free survival (PFS).

Outcome measures

Outcome measures
Measure	Neck Dissection n=33 Participants Patients undergo up-front neck dissection of the cervical lymph nodes to determine stratification into one of three standard-of-care treatment groups: transoral surgery of the primary site, radiation or chemoradiation. Neck Dissection: All patients will undergo neck dissection of the cervical lymph nodes Standard-of-Care (SOC) Transoral Surgery of Primary Site: Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site. SOC Radiation: Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation. SOC Carboplatin: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). SOC Paclitaxel: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). Videofluoroscopy: All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function.
Progression Free Survival (PFS)	97 percentage of participants Interval 76.0 to 99.0

SECONDARY outcome

Timeframe: 3 Years

Proportion of patients alive at 3 years from date of neck dissection. Death from any cause will be considered an event for overall survival.

Outcome measures

Outcome measures
Measure	Neck Dissection n=33 Participants Patients undergo up-front neck dissection of the cervical lymph nodes to determine stratification into one of three standard-of-care treatment groups: transoral surgery of the primary site, radiation or chemoradiation. Neck Dissection: All patients will undergo neck dissection of the cervical lymph nodes Standard-of-Care (SOC) Transoral Surgery of Primary Site: Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site. SOC Radiation: Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation. SOC Carboplatin: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). SOC Paclitaxel: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation (Radiation, Carboplatin and Paclitaxel). Videofluoroscopy: All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function.
Overall Survival (OS)	100 Percent of Patients

Adverse Events

Neck Dissection

Serious events: 3 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Neck Dissection n=34 participants at risk Patients undergo up-front neck dissection of the cervical lymph nodes to determine stratification into one of three standard-of-care treatment groups: transoral surgery of the primary site, radiation or chemoradiation: Neck Dissection: All patients will undergo neck dissection of the cervical lymph nodes SOC Transoral Surgery of Primary Site: Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site. SOC Radiation: Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation. SOC Carboplatin: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation. SOC Paclitaxel: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation. Videofluoroscopy: All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function. All patients, regardless of intervention were combined into one arm for analysis
Gastrointestinal disorders Mucositis oral	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Gastrointestinal disorders Oral Hemorrhage	5.9% 2/34 • Number of events 2 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years

Other adverse events

Other adverse events
Measure	Neck Dissection n=34 participants at risk Patients undergo up-front neck dissection of the cervical lymph nodes to determine stratification into one of three standard-of-care treatment groups: transoral surgery of the primary site, radiation or chemoradiation: Neck Dissection: All patients will undergo neck dissection of the cervical lymph nodes SOC Transoral Surgery of Primary Site: Patients with a single lymph node that measures less than six centimeters, have no extracapsular extension in the lymph node, and have no perineural or perivascular invasion of the primary biopsy will undergo transoral surgery of the primary site. SOC Radiation: Patients who have 2 positive nodes with no extracapsular extension, or have perineural or perivascular invasion of the primary biopsy will undergo radiation. SOC Carboplatin: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation. SOC Paclitaxel: Patients who have extracapsular extension in any number of lymph nodes or in those patients in whom negative margins are unable to be obtained after the completion of transoral surgery will undergo chemoradiation. Videofluoroscopy: All patients undergo a videofluoroscopy procedure one year after completion of therapy to assess swallowing function. All patients, regardless of intervention were combined into one arm for analysis
Gastrointestinal disorders Abdominal pain	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Investigations Alkaline phosphatase increased	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Skin and subcutaneous tissue disorders Alopecia	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Investigations Anemia	8.8% 3/34 • Number of events 3 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Metabolism and nutrition disorders Anorexia	17.6% 6/34 • Number of events 6 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Psychiatric disorders Anxiety	11.8% 4/34 • Number of events 5 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Musculoskeletal and connective tissue disorders Arthralgia	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Musculoskeletal and connective tissue disorders Arthritis	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Respiratory, thoracic and mediastinal disorders Aspiration	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Musculoskeletal and connective tissue disorders Avascular necrosis	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Musculoskeletal and connective tissue disorders Back Pain	5.9% 2/34 • Number of events 2 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Investigations Blood bilirubin increased	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Musculoskeletal and connective tissue disorders Buttock pain	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Cardiac disorders Cardiac disorders- Other	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Musculoskeletal and connective tissue disorders chest wall pain	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Gastrointestinal disorders Constipation	41.2% 14/34 • Number of events 16 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Respiratory, thoracic and mediastinal disorders Cough	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Investigations Creatinine increased	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Metabolism and nutrition disorders Dehydration	17.6% 6/34 • Number of events 9 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Psychiatric disorders Depression	11.8% 4/34 • Number of events 4 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Skin and subcutaneous tissue disorders Dermatitis radiation	32.4% 11/34 • Number of events 15 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Gastrointestinal disorders Diarrhea	5.9% 2/34 • Number of events 2 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Nervous system disorders Dizziness	8.8% 3/34 • Number of events 3 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Gastrointestinal disorders Dry mouth	58.8% 20/34 • Number of events 35 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Skin and subcutaneous tissue disorders Dry skin	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Nervous system disorders Dysgeusia	55.9% 19/34 • Number of events 34 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Gastrointestinal disorders Dysphagia	50.0% 17/34 • Number of events 29 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Respiratory, thoracic and mediastinal disorders Dyspnea	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Ear and labyrinth disorders Ear and labyrinth disorders - Other	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Ear and labyrinth disorders Ear pain	14.7% 5/34 • Number of events 8 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
General disorders Edema face	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
General disorders Edema limbs	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Gastrointestinal disorders Esophageal pain	17.6% 6/34 • Number of events 10 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Gastrointestinal disorders Esophageal ulcer	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Gastrointestinal disorders Esophagitis	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Nervous system disorders Facial muscle weakness	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
General disorders Facial pain	5.9% 2/34 • Number of events 2 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
General disorders Fatigue	41.2% 14/34 • Number of events 22 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Musculoskeletal and connective tissue disorders Flank pain	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Gastrointestinal disorders Gastroesophageal reflux disease	8.8% 3/34 • Number of events 3 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Gastrointestinal disorders Gastrointestinal disorders - Other	5.9% 2/34 • Number of events 2 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
General disorders General disorders and administration site conditions- Other	29.4% 10/34 • Number of events 18 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Musculoskeletal and connective tissue disorders Generalized muscle weakness	5.9% 2/34 • Number of events 2 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Nervous system disorders Headache	11.8% 4/34 • Number of events 6 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Ear and labyrinth disorders Hearing impaired	8.8% 3/34 • Number of events 3 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Respiratory, thoracic and mediastinal disorders Hoarseness	17.6% 6/34 • Number of events 6 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Vascular disorders Hot flashes	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Investigations Hyperglycemia	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Vascular disorders Hypertension	17.6% 6/34 • Number of events 7 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Metabolism and nutrition disorders Hypocalcemia	2.9% 1/34 • Number of events 2 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Metabolism and nutrition disorders Hypomagnesemia	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Metabolism and nutrition disorders Hyponatremia	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Vascular disorders Hypotension	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Endocrine disorders Hypothyroidism	5.9% 2/34 • Number of events 2 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Infections and infestations Infections and infestations - Other	11.8% 4/34 • Number of events 5 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Psychiatric disorders Insomnia	11.8% 4/34 • Number of events 4 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Musculoskeletal and connective tissue disorders Joint range of motion decreased lumbar spine	5.9% 2/34 • Number of events 2 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	5.9% 2/34 • Number of events 2 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
General disorders Localized edema	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Vascular disorders Lymphedema	17.6% 6/34 • Number of events 6 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Investigations Lymphocyte count decreased	8.8% 3/34 • Number of events 7 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Nervous system disorders Meningismus	5.9% 2/34 • Number of events 2 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other	5.9% 2/34 • Number of events 2 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Infections and infestations Mucosal infection	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Gastrointestinal disorders Mucositis oral	38.2% 13/34 • Number of events 20 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Musculoskeletal and connective tissue disorders Muscle weakness trunk	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	8.8% 3/34 • Number of events 3 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	14.7% 5/34 • Number of events 5 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Musculoskeletal and connective tissue disorders Myalgia	17.6% 6/34 • Number of events 10 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.9% 2/34 • Number of events 2 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Gastrointestinal disorders Nausea	44.1% 15/34 • Number of events 19 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Musculoskeletal and connective tissue disorders Neck pain	26.5% 9/34 • Number of events 11 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other	5.9% 2/34 • Number of events 2 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
General disorders Non-cardiac chest pain	5.9% 2/34 • Number of events 2 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Gastrointestinal disorders Oral dysesthesia	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Gastrointestinal disorders Oral pain	41.2% 14/34 • Number of events 21 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Musculoskeletal and connective tissue disorders Osteoporosis	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
General disorders Pain	41.2% 14/34 • Number of events 30 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Musculoskeletal and connective tissue disorders Pain in extremity	5.9% 2/34 • Number of events 2 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Cardiac disorders Palpitations	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Gastrointestinal disorders Pancreatitis	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Skin and subcutaneous tissue disorders Papulopustular rash	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Nervous system disorders Paresthesia	8.8% 3/34 • Number of events 3 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Nervous system disorders Peripheral motor neuropathy	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Psychiatric disorders Personality change	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Injury, poisoning and procedural complications Postoperative hemorrhage	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Respiratory, thoracic and mediastinal disorders Productive cough	5.9% 2/34 • Number of events 3 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Skin and subcutaneous tissue disorders Rash acneiform	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Skin and subcutaneous tissue disorders Rash maculo-papular	5.9% 2/34 • Number of events 2 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Renal and urinary disorders Renal and urinary disorders - Other	5.9% 2/34 • Number of events 2 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Injury, poisoning and procedural complications Seroma	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	8.8% 3/34 • Number of events 3 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Skin and subcutaneous tissue disorders Skin infection	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Skin and subcutaneous tissue disorders Skin ulceration	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Respiratory, thoracic and mediastinal disorders Sleep apnea	5.9% 2/34 • Number of events 2 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Respiratory, thoracic and mediastinal disorders Sore throat	29.4% 10/34 • Number of events 12 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Injury, poisoning and procedural complications Spinal fracture	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Gastrointestinal disorders Stomach pain	5.9% 2/34 • Number of events 2 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Musculoskeletal and connective tissue disorders Superficial soft tissue fibrosis	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Surgical and medical procedures Surgical and medical procedures - Other	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Nervous system disorders Syncope	5.9% 2/34 • Number of events 3 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Reproductive system and breast disorders Testicular disorder	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Ear and labyrinth disorders Tinnitus	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Musculoskeletal and connective tissue disorders Trismus	17.6% 6/34 • Number of events 6 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	5.9% 2/34 • Number of events 2 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Renal and urinary disorders Urinary retention	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Ear and labyrinth disorders Vertigo	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Respiratory, thoracic and mediastinal disorders Voice alteration	11.8% 4/34 • Number of events 4 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Gastrointestinal disorders Vomiting	20.6% 7/34 • Number of events 7 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Investigations Weight gain	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Investigations Weight loss	41.2% 14/34 • Number of events 14 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years
Investigations White blood cell decreased	2.9% 1/34 • Number of events 1 • up to 12 months post treatment for Adverse Events, Serious Adverse Events up to 4 weeks post treatment, All-Cause Mortality assessed up to 3 years

Additional Information

Paul Swiecicki

University of Michigan

Phone: 734-647-1017

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place