Trial Outcomes & Findings for Neodjuvant Nivolumab and Lirilumab, Followed by Surgery, Followed by Adjuvant Nivolumab and Lirilumab, in SCCHN (NCT NCT03341936)

NCT ID: NCT03341936

Last Updated: 2025-06-18

Results Overview

The percentage of patients who were alive and disease free at one year past salvage surgery. Patients who were alive at last contact prior to the one year mark are censored. Data analysis conducted through Kaplan Meier methods.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

29 participants

Primary outcome timeframe

1 year since salvage surgery, up to 1 year and 23 days since treatment start

Results posted on

2025-06-18

Participant Flow

Enrollment Period March 2018 to May 2020

Participant milestones

Participant milestones
Measure	Nivolumab+Lirilumab * The drugs will be administered intravenously. A single dose of Nivolumab and Lirilumab will be administered prior Salvage surgical resection. * In Cycle 1-3: Nivolumab will be administered on Days 1 and 15 and lirilumab will be administered on Day 1 of each 28 day long cycle * In Cycle 4-6 and beyond: Nivolumab and lirilumab will be administered on Day 1 of each 28 day long cycle. Nivolumab: Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells Lirilumab: Lirilumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells
Overall Study STARTED	29
Overall Study Treated	28
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Nivolumab+Lirilumab * The drugs will be administered intravenously. A single dose of Nivolumab and Lirilumab will be administered prior Salvage surgical resection. * In Cycle 1-3: Nivolumab will be administered on Days 1 and 15 and lirilumab will be administered on Day 1 of each 28 day long cycle * In Cycle 4-6 and beyond: Nivolumab and lirilumab will be administered on Day 1 of each 28 day long cycle. Nivolumab: Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells Lirilumab: Lirilumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells
Overall Study Ineligible	1
Overall Study Disease Progression	2
Overall Study Withdrew Consent	4
Overall Study Non-Compliance	1
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	1
Overall Study Other	1

Baseline Characteristics

Neodjuvant Nivolumab and Lirilumab, Followed by Surgery, Followed by Adjuvant Nivolumab and Lirilumab, in SCCHN

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nivolumab+Lirilumab n=28 Participants * The drugs will be administered intravenously. A single dose of Nivolumab and Lirilumab will be administered prior Salvage surgical resection. * In Cycle 1-3: Nivolumab will be administered on Days 1 and 15 and lirilumab will be administered on Day 1 of each 28 day long cycle * In Cycle 4-6 and beyond: Nivolumab and lirilumab will be administered on Day 1 of each 28 day long cycle. Nivolumab: Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells Lirilumab: Lirilumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells
Age, Continuous	66 years n=99 Participants
Sex: Female, Male Female	5 Participants n=99 Participants
Sex: Female, Male Male	23 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants
Race (NIH/OMB) White	26 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants

PRIMARY outcome

Timeframe: 1 year since salvage surgery, up to 1 year and 23 days since treatment start

Outcome measures

Outcome measures
Measure	Nivolumab+Lirilumab n=28 Participants * The drugs will be administered intravenously. A single dose of Nivolumab and Lirilumab will be administered prior Salvage surgical resection. * In Cycle 1-3: Nivolumab will be administered on Days 1 and 15 and lirilumab will be administered on Day 1 of each 28 day long cycle * In Cycle 4-6 and beyond: Nivolumab and lirilumab will be administered on Day 1 of each 28 day long cycle. Nivolumab: Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells Lirilumab: Lirilumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells
1-Year Disease-Free Survival Percentage	55.2 percentage of participants Interval 34.8 to 71.7

SECONDARY outcome

Timeframe: At the time of salvage surgery, up to 23 days from treatment start date.

Response is classified using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Complete Response - Disappearance of all lesions and pathologic lymph nodes. Partial Response - At least 30% decrease in sum of longest diameters (SLD) for the target lesions, no new lesions, and no progression of non-target lesions. Progressive Disease - At least 20% increase in SLD compared to smallest SLD in study or progression of non-target lesions or development of new lesions Stable Disease - No Partial Response and no Progressive Disease.

Outcome measures

Outcome measures
Measure	Nivolumab+Lirilumab n=28 Participants * The drugs will be administered intravenously. A single dose of Nivolumab and Lirilumab will be administered prior Salvage surgical resection. * In Cycle 1-3: Nivolumab will be administered on Days 1 and 15 and lirilumab will be administered on Day 1 of each 28 day long cycle * In Cycle 4-6 and beyond: Nivolumab and lirilumab will be administered on Day 1 of each 28 day long cycle. Nivolumab: Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells Lirilumab: Lirilumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells
Response at Time of Salvage Surgery Stable Disease	27 Participants
Response at Time of Salvage Surgery Progressive Disease	1 Participants

SECONDARY outcome

Timeframe: Up to 27.2 months post salvage surgery, up to 28 months total.

The median time that patients were alive and disease free after salvage surgery. Patients who were alive at last contact are censored at last contact. Data analysis conducted through Kaplan Meier methods

Outcome measures

Outcome measures
Measure	Nivolumab+Lirilumab n=28 Participants * The drugs will be administered intravenously. A single dose of Nivolumab and Lirilumab will be administered prior Salvage surgical resection. * In Cycle 1-3: Nivolumab will be administered on Days 1 and 15 and lirilumab will be administered on Day 1 of each 28 day long cycle * In Cycle 4-6 and beyond: Nivolumab and lirilumab will be administered on Day 1 of each 28 day long cycle. Nivolumab: Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells Lirilumab: Lirilumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells
Median Disease-Free Survival Rate	12.9 months Interval 8.18 to The last patient was censored at 27.2 months and therefore an upper limit was not reached due to an insufficient number of participants with events at data cutoff.

SECONDARY outcome

Timeframe: 1 year post salvage surgery, up to 1 year and 23 days post treatment start.

Percentage of participants who were alive at 1 year since salvage surgery. Patients alive at last contact prior to 1 year were censored.

Outcome measures

Outcome measures
Measure	Nivolumab+Lirilumab n=28 Participants * The drugs will be administered intravenously. A single dose of Nivolumab and Lirilumab will be administered prior Salvage surgical resection. * In Cycle 1-3: Nivolumab will be administered on Days 1 and 15 and lirilumab will be administered on Day 1 of each 28 day long cycle * In Cycle 4-6 and beyond: Nivolumab and lirilumab will be administered on Day 1 of each 28 day long cycle. Nivolumab: Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells Lirilumab: Lirilumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells
1-Year Overall Survival Percentage	85.7 percentage of participants Interval 66.3 to 94.4

SECONDARY outcome

Timeframe: Measured at baseline and then at time of salvage surgery, up to 23 days.

Population: Outcomes were compared among responders and non-responders.

The median change in Programmed Cell Death Ligand - 1 Combined Positive Score (PD-L1 CPS) from baseline to surgery. The score is derived from tumor tissue samples that measures the presence of both tumor and immune cell staining for the PD-L1 marker. Scored from 0-100, a higher score suggests the patient might respond better to treatment. A pathological responder is defined as having less than 50% viable tumor at the time of surgery.

Outcome measures

Outcome measures
Measure	Nivolumab+Lirilumab n=28 Participants * The drugs will be administered intravenously. A single dose of Nivolumab and Lirilumab will be administered prior Salvage surgical resection. * In Cycle 1-3: Nivolumab will be administered on Days 1 and 15 and lirilumab will be administered on Day 1 of each 28 day long cycle * In Cycle 4-6 and beyond: Nivolumab and lirilumab will be administered on Day 1 of each 28 day long cycle. Nivolumab: Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells Lirilumab: Lirilumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells
Median Change in Programmed Cell Death Ligand - 1 Combined Positive Score Responder	2.5 score Interval -45.0 to 75.0
Median Change in Programmed Cell Death Ligand - 1 Combined Positive Score Non-Responder	0 score Interval -45.0 to 49.0

Adverse Events

Nivolumab+Lirilumab

Serious events: 12 serious events

Other events: 28 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Nivolumab+Lirilumab n=28 participants at risk * The drugs will be administered intravenously. A single dose of Nivolumab and Lirilumab will be administered prior Salvage surgical resection. * In Cycle 1-3: Nivolumab will be administered on Days 1 and 15 and lirilumab will be administered on Day 1 of each 28 day long cycle * In Cycle 4-6 and beyond: Nivolumab and lirilumab will be administered on Day 1 of each 28 day long cycle. Nivolumab: Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells Lirilumab: Lirilumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells
Cardiac disorders Cardiac arrest	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Cardiac disorders Chest pain - cardiac	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Cardiac disorders Myocardial infarction	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Gastrointestinal disorders Dysphagia	10.7% 3/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Gastrointestinal disorders Nausea	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
General disorders Infusion related reaction	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Infections and infestations Lung infection	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Infections and infestations Wound infection	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Infections and infestations Infections and infestations - Other, specify	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Injury, poisoning and procedural complications Wound dehiscence	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Respiratory, thoracic and mediastinal disorders Dyspnea	14.3% 4/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Respiratory, thoracic and mediastinal disorders Laryngeal fistula	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Respiratory, thoracic and mediastinal disorders Productive cough	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.

Other adverse events

Other adverse events
Measure	Nivolumab+Lirilumab n=28 participants at risk * The drugs will be administered intravenously. A single dose of Nivolumab and Lirilumab will be administered prior Salvage surgical resection. * In Cycle 1-3: Nivolumab will be administered on Days 1 and 15 and lirilumab will be administered on Day 1 of each 28 day long cycle * In Cycle 4-6 and beyond: Nivolumab and lirilumab will be administered on Day 1 of each 28 day long cycle. Nivolumab: Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells Lirilumab: Lirilumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells
Infections and infestations Sinusitis	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Infections and infestations Stoma site infection	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Infections and infestations Tooth infection	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Infections and infestations Upper respiratory infection	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Infections and infestations Urinary tract infection	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Blood and lymphatic system disorders Anemia	25.0% 7/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Cardiac disorders Sinus bradycardia	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Ear and labyrinth disorders Ear pain	28.6% 8/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Ear and labyrinth disorders Hearing impaired	14.3% 4/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Ear and labyrinth disorders Tinnitus	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Endocrine disorders Hypothyroidism	64.3% 18/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Endocrine disorders Endocrine disorders - Other, specify	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Eye disorders Conjunctivitis	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Eye disorders Retinal detachment	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Gastrointestinal disorders Abdominal pain	10.7% 3/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Gastrointestinal disorders Bloating	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Gastrointestinal disorders Cheilitis	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Gastrointestinal disorders Constipation	21.4% 6/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Gastrointestinal disorders Diarrhea	39.3% 11/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Gastrointestinal disorders Dry mouth	39.3% 11/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Gastrointestinal disorders Dysphagia	96.4% 27/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Gastrointestinal disorders Esophageal stenosis	10.7% 3/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Gastrointestinal disorders Flatulence	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Gastrointestinal disorders Gastritis	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Gastrointestinal disorders Gastroesophageal reflux disease	17.9% 5/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Gastrointestinal disorders Hemorrhoids	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Gastrointestinal disorders Lip pain	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Gastrointestinal disorders Nausea	21.4% 6/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Gastrointestinal disorders Oral cavity fistula	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Gastrointestinal disorders Oral dysesthesia	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Gastrointestinal disorders Oral pain	32.1% 9/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Gastrointestinal disorders Stomach pain	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Gastrointestinal disorders Vomiting	14.3% 4/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
General disorders Chills	21.4% 6/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
General disorders Edema face	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
General disorders Edema limbs	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
General disorders Facial pain	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
General disorders Fatigue	71.4% 20/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
General disorders Fever	17.9% 5/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
General disorders Gait disturbance	10.7% 3/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
General disorders Infusion related reaction	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
General disorders Localized edema	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
General disorders Neck edema	14.3% 4/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
General disorders Non-cardiac chest pain	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
General disorders Pain	50.0% 14/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
General disorders General disorders and administration site conditions - Other, specify	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Infections and infestations Biliary tract infection	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Infections and infestations Conjunctivitis infective	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Infections and infestations Lung infection	10.7% 3/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Infections and infestations Mucosal infection	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Infections and infestations Pharyngitis	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Infections and infestations Infections and infestations - Other, specify	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Injury, poisoning and procedural complications Fall	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Injury, poisoning and procedural complications Seroma	10.7% 3/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Injury, poisoning and procedural complications Tracheostomy site bleeding	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Injury, poisoning and procedural complications Wound complication	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Injury, poisoning and procedural complications Wound dehiscence	10.7% 3/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Investigations Alanine aminotransferase increased	17.9% 5/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Investigations Alkaline phosphatase increased	14.3% 4/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Investigations Aspartate aminotransferase increased	28.6% 8/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Investigations Blood bilirubin increased	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Investigations Cholesterol high	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Investigations Creatinine increased	14.3% 4/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Investigations Weight loss	10.7% 3/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Investigations Investigations - Other, specify	10.7% 3/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Metabolism and nutrition disorders Anorexia	14.3% 4/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Metabolism and nutrition disorders Dehydration	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Metabolism and nutrition disorders Hypercalcemia	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Metabolism and nutrition disorders Hyperglycemia	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Metabolism and nutrition disorders Hyperkalemia	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Metabolism and nutrition disorders Hypermagnesemia	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Metabolism and nutrition disorders Hypoglycemia	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Metabolism and nutrition disorders Hypokalemia	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Metabolism and nutrition disorders Hypomagnesemia	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Metabolism and nutrition disorders Hyponatremia	10.7% 3/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Metabolism and nutrition disorders Hypophosphatemia	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 4/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Musculoskeletal and connective tissue disorders Arthritis	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Musculoskeletal and connective tissue disorders Back pain	17.9% 5/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	10.7% 3/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Musculoskeletal and connective tissue disorders Myalgia	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Musculoskeletal and connective tissue disorders Neck pain	35.7% 10/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Musculoskeletal and connective tissue disorders Pain in extremity	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Nervous system disorders Aphonia	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Nervous system disorders Dizziness	10.7% 3/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Nervous system disorders Dysarthria	14.3% 4/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Nervous system disorders Dysgeusia	10.7% 3/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Nervous system disorders Headache	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Nervous system disorders Movements involuntary	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Nervous system disorders Paresthesia	10.7% 3/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Nervous system disorders Peripheral sensory neuropathy	10.7% 3/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Nervous system disorders Presyncope	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Nervous system disorders Vasovagal reaction	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Psychiatric disorders Anxiety	17.9% 5/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Psychiatric disorders Confusion	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Psychiatric disorders Delirium	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Psychiatric disorders Depression	25.0% 7/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Psychiatric disorders Insomnia	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Psychiatric disorders Psychosis	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Renal and urinary disorders Hematuria	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Renal and urinary disorders Urinary retention	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Renal and urinary disorders Renal and urinary disorders - Other, specify	14.3% 4/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Respiratory, thoracic and mediastinal disorders Aspiration	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Respiratory, thoracic and mediastinal disorders Cough	35.7% 10/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Respiratory, thoracic and mediastinal disorders Dyspnea	17.9% 5/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Respiratory, thoracic and mediastinal disorders Hypoxia	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Respiratory, thoracic and mediastinal disorders Pharyngeal fistula	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Respiratory, thoracic and mediastinal disorders Productive cough	14.3% 4/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Respiratory, thoracic and mediastinal disorders Sore throat	21.4% 6/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Respiratory, thoracic and mediastinal disorders Tracheal fistula	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Respiratory, thoracic and mediastinal disorders Tracheal stenosis	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Respiratory, thoracic and mediastinal disorders Voice alteration	46.4% 13/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	53.6% 15/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Skin and subcutaneous tissue disorders Alopecia	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Skin and subcutaneous tissue disorders Dry skin	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Skin and subcutaneous tissue disorders Erythema multiforme	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Skin and subcutaneous tissue disorders Pain of skin	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Skin and subcutaneous tissue disorders Pruritus	14.3% 4/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Skin and subcutaneous tissue disorders Rash maculo-papular	10.7% 3/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Skin and subcutaneous tissue disorders Skin induration	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	3.6% 1/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Vascular disorders Hematoma	7.1% 2/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Vascular disorders Hypertension	25.0% 7/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.
Vascular disorders Hypotension	10.7% 3/28 • All-Cause Mortality was monitored for 1 year post salvage surgery, up to 1 year and 23 days post treatment start. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored from baseline to end of adjuvant therapy, up to 9 months. A serious adverse event is classified using physician's discretion. All adverse events resulting in death, life threatening events, significant disability, prolonged hospitalization, congenital abnormality/birth defect, or new cancer will be considered a serious adverse event.

Additional Information

Glenn J. Hanna, MD

Dana Farber Cancer Institute

Phone: 6176326799

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place