Trial Outcomes & Findings for Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers (NCT NCT03515538)

Last Updated: 2024-11-04

Results Overview

Duration in days of severe oral mucositis (SOM). Defined as oral mucositis grade 3 or 4 on the WHO Mucositis Grading Scale which comprises 5 grades: 0 = none, 1= oral soreness, erythema, 2 = oral erythema, ulcers, solid diet tolerated, 3 = oral ulcers, liquid diet only, and 4 = oral alimentation impossible. Severe Oral Mucositis duration is obtained by totaling the number of days a given patient experiences oral mucositis grade 3 or 4 during the randomized treatment period. Higher Severe Oral Mucositis duration numbers are indicative of worst outcomes. The total Severe Oral Mucositis duration for a given patient will range between 0 days and the maximum number of days the patient participated in the randomized treatment period.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

53 participants

Primary outcome timeframe

From start of treatment through 28 days post treatment for up to 11 weeks from Start of Treatment

Results posted on

2024-11-04

Participant Flow

Participant milestones

Participant milestones
Measure	RRx-001 Pre-Treatment Plus SOC Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC (four doses total). No additional RRx-001 will be given during the course of RT/cisplatin RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	RRx-001 Pre-Treatment, 2 Concurrent Doses Plus SOC Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day in each of weeks 2 and 5 during RT/cisplatin administration RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	RRx-001 Pre-Treatment, 6 Concurrent Doses Plus SOC Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day of each of the first 6 weeks during RT/cisplatin administration RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	Standard of Care No doses of RRx-001 will be administered. Patients assigned to this arm will receive only standard of care in the form of a 7-week course of fractionated radiation therapy concurrent with a high-dose cisplatin regimen (100 mg/m2 dose in each of RT weeks 1, 4, and 7). Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study
Overall Study STARTED	14	13	13	13
Overall Study COMPLETED	9	10	9	8
Overall Study NOT COMPLETED	5	3	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	RRx-001 Pre-Treatment Plus SOC Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC (four doses total). No additional RRx-001 will be given during the course of RT/cisplatin RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	RRx-001 Pre-Treatment, 2 Concurrent Doses Plus SOC Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day in each of weeks 2 and 5 during RT/cisplatin administration RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	RRx-001 Pre-Treatment, 6 Concurrent Doses Plus SOC Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day of each of the first 6 weeks during RT/cisplatin administration RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	Standard of Care No doses of RRx-001 will be administered. Patients assigned to this arm will receive only standard of care in the form of a 7-week course of fractionated radiation therapy concurrent with a high-dose cisplatin regimen (100 mg/m2 dose in each of RT weeks 1, 4, and 7). Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study
Overall Study Lack of Efficacy	2	0	2	0
Overall Study Death	0	0	1	0
Overall Study Protocol Violation	0	0	0	1
Overall Study Screen failure (baseline dropout)	0	1	0	0
Overall Study Withdrawal by Subject	2	2	1	3
Overall Study Physician Decision	1	0	0	1

Baseline Characteristics

Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RRx-001 Pre-Treatment Plus SOC n=12 Participants Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC (four doses total). No additional RRx-001 will be given during the course of RT/cisplatin RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	RRx-001 Pre-Treatment, 2 Concurrent Doses Plus SOC n=11 Participants Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day in each of weeks 2 and 5 during RT/cisplatin administration RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	RRx-001 Pre-Treatment, 6 Concurrent Doses Plus SOC n=13 Participants Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day of each of the first 6 weeks during RT/cisplatin administration RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	Standard of Care n=10 Participants No doses of RRx-001 will be administered. Patients assigned to this arm will receive only standard of care in the form of a 7-week course of fractionated radiation therapy concurrent with a high-dose cisplatin regimen (100 mg/m2 dose in each of RT weeks 1, 4, and 7). Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	Total n=46 Participants Total of all reporting groups
Age, Continuous	57.7 years STANDARD_DEVIATION 11.17 • n=99 Participants	56.7 years STANDARD_DEVIATION 7.64 • n=107 Participants	59 years STANDARD_DEVIATION 11.94 • n=206 Participants	59.5 years STANDARD_DEVIATION 6.0 • n=7 Participants	58.2 years STANDARD_DEVIATION 9.48 • n=31 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	2 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=7 Participants	6 Participants n=31 Participants
Sex: Female, Male Male	10 Participants n=99 Participants	9 Participants n=107 Participants	12 Participants n=206 Participants	9 Participants n=7 Participants	40 Participants n=31 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	2 Participants n=31 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=99 Participants	10 Participants n=107 Participants	13 Participants n=206 Participants	9 Participants n=7 Participants	43 Participants n=31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants
Race/Ethnicity, Customized Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=7 Participants	2 Participants n=31 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	3 Participants n=31 Participants
Race/Ethnicity, Customized White	11 Participants n=99 Participants	10 Participants n=107 Participants	12 Participants n=206 Participants	8 Participants n=7 Participants	41 Participants n=31 Participants
Region of Enrollment United States	12 participants n=99 Participants	11 participants n=107 Participants	13 participants n=206 Participants	10 participants n=7 Participants	46 participants n=31 Participants

PRIMARY outcome

Timeframe: From start of treatment through 28 days post treatment for up to 11 weeks from Start of Treatment

Population: All participants: number of days from the start of oral mucositis greater than a grade zero until resolution.

Outcome measures

Outcome measures
Measure	RRx-001 Pre-Treatment Plus SOC n=12 Participants Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC (four doses total). No additional RRx-001 will be given during the course of RT/cisplatin RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	RRx-001 Pre-Treatment, 2 Concurrent Doses Plus SOC n=10 Participants Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day in each of weeks 2 and 5 during RT/cisplatin administration RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	RRx-001 Pre-Treatment, 6 Concurrent Doses Plus SOC n=13 Participants Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day of each of the first 6 weeks during RT/cisplatin administration RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	Standard of Care n=10 Participants No doses of RRx-001 will be administered. Patients assigned to this arm will receive only standard of care in the form of a 7-week course of fractionated radiation therapy concurrent with a high-dose cisplatin regimen (100 mg/m2 dose in each of RT weeks 1, 4, and 7). Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study
Duration of Severe Oral Mucositis (SOM)	22.9 Days Standard Deviation 19.08	27.7 Days Standard Deviation 23.72	35.2 Days Standard Deviation 28.83	37.8 Days Standard Deviation 29.33

SECONDARY outcome

Timeframe: Time from Day 1 to Oral Mucositis Onset (up to 8 weeks)

Population: All participants: number of days from start of treatment until participant experiences a OM grade of greater than zero.

Time to onset of Severe Oral Mucositis defined as time (in days) from randomization to the first observed Severe Oral Mucositis. Longer Severe Oral Mucositis onset times are indicative of a better outcome. The time to onset of Severe Oral Mucositis for a given patient will range between 0 days and the maximum number of days the patient participated in the randomized treatment period.

Outcome measures

Outcome measures
Measure	RRx-001 Pre-Treatment Plus SOC n=12 Participants Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC (four doses total). No additional RRx-001 will be given during the course of RT/cisplatin RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	RRx-001 Pre-Treatment, 2 Concurrent Doses Plus SOC n=10 Participants Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day in each of weeks 2 and 5 during RT/cisplatin administration RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	RRx-001 Pre-Treatment, 6 Concurrent Doses Plus SOC n=13 Participants Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day of each of the first 6 weeks during RT/cisplatin administration RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	Standard of Care n=10 Participants No doses of RRx-001 will be administered. Patients assigned to this arm will receive only standard of care in the form of a 7-week course of fractionated radiation therapy concurrent with a high-dose cisplatin regimen (100 mg/m2 dose in each of RT weeks 1, 4, and 7). Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study
Time to Onset of Severe Oral Mucositis	38 Days to Onset Interval 26.0 to insufficient number of participants with events	33 Days to Onset Interval 22.0 to insufficient number of participants with events	37 Days to Onset Interval 22.0 to insufficient number of participants with events	26 Days to Onset Interval 18.0 to insufficient number of participants with events

SECONDARY outcome

Timeframe: Baseline through end of treatment (up to 11 weeks). Data collected every week.

Population: All participants who received study treatment and who experienced Oral Mucositis score greater than zero.

Incidence of Severe Oral Mucositis defined as the number of patients who experienced a Severe Oral Mucositis grade 4 during the randomized treatment period.

Outcome measures

Outcome measures
Measure	RRx-001 Pre-Treatment Plus SOC n=12 Participants Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC (four doses total). No additional RRx-001 will be given during the course of RT/cisplatin RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	RRx-001 Pre-Treatment, 2 Concurrent Doses Plus SOC n=10 Participants Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day in each of weeks 2 and 5 during RT/cisplatin administration RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	RRx-001 Pre-Treatment, 6 Concurrent Doses Plus SOC n=13 Participants Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day of each of the first 6 weeks during RT/cisplatin administration RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	Standard of Care n=10 Participants No doses of RRx-001 will be administered. Patients assigned to this arm will receive only standard of care in the form of a 7-week course of fractionated radiation therapy concurrent with a high-dose cisplatin regimen (100 mg/m2 dose in each of RT weeks 1, 4, and 7). Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study
Incidence of Severe Oral Mucositis	0 Participants	4 Participants	6 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline through end of radiation treatment (through 8 weeks). Data collected every week.

Population: Participants who required opioid use during treatment.

Opioid use from the time to onset (TTO) and duration of opioid use among patients who were not taking opioids at radiation start or who required a second opioid during active treatment.

Outcome measures

Outcome measures
Measure	RRx-001 Pre-Treatment Plus SOC n=12 Participants Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC (four doses total). No additional RRx-001 will be given during the course of RT/cisplatin RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	RRx-001 Pre-Treatment, 2 Concurrent Doses Plus SOC n=10 Participants Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day in each of weeks 2 and 5 during RT/cisplatin administration RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	RRx-001 Pre-Treatment, 6 Concurrent Doses Plus SOC n=13 Participants Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day of each of the first 6 weeks during RT/cisplatin administration RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	Standard of Care n=9 Participants No doses of RRx-001 will be administered. Patients assigned to this arm will receive only standard of care in the form of a 7-week course of fractionated radiation therapy concurrent with a high-dose cisplatin regimen (100 mg/m2 dose in each of RT weeks 1, 4, and 7). Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study
Opioid Use Week 1	1 Participants	0 Participants	0 Participants	1 Participants
Opioid Use Week 2	2 Participants	0 Participants	1 Participants	2 Participants
Opioid Use Week 3	4 Participants	2 Participants	2 Participants	4 Participants
Opioid Use Week 4	4 Participants	2 Participants	2 Participants	4 Participants
Opioid Use Week 5	4 Participants	2 Participants	3 Participants	4 Participants
Opioid Use Week 6	4 Participants	2 Participants	3 Participants	4 Participants
Opioid Use Week 7	4 Participants	2 Participants	3 Participants	4 Participants
Opioid Use Week 8	4 Participants	2 Participants	4 Participants	5 Participants

Adverse Events

RRx-001 Pre-Treatment Plus SOC

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

RRx-001 Pre-Treatment, 2 Concurrent Doses Plus SOC

Serious events: 4 serious events

Other events: 10 other events

Deaths: 0 deaths

RRx-001 Pre-Treatment, 6 Concurrent Doses Plus SOC

Serious events: 6 serious events

Other events: 12 other events

Deaths: 1 deaths

Standard of Care

Serious events: 5 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Bryan Oronsky

EpicentRx, Inc

Phone: 858-229-1062

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	RRx-001 Pre-Treatment Plus SOC n=12 participants at risk Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC (four doses total). No additional RRx-001 will be given during the course of RT/cisplatin RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	RRx-001 Pre-Treatment, 2 Concurrent Doses Plus SOC n=11 participants at risk Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day in each of weeks 2 and 5 during RT/cisplatin administration RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	RRx-001 Pre-Treatment, 6 Concurrent Doses Plus SOC n=13 participants at risk Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day of each of the first 6 weeks during RT/cisplatin administration RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	Standard of Care n=10 participants at risk No doses of RRx-001 will be administered. Patients assigned to this arm will receive only standard of care in the form of a 7-week course of fractionated radiation therapy concurrent with a high-dose cisplatin regimen (100 mg/m2 dose in each of RT weeks 1, 4, and 7). Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study
Blood and lymphatic system disorders Febrile neutropenia	8.3% 1/12 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Cardiac disorders Atrial fibrillation	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	10.0% 1/10 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Cardiac disorders Atrial flutter	8.3% 1/12 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Colitis	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	9.1% 1/11 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Gastric perforation	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Nausea	8.3% 1/12 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	9.1% 1/11 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	10.0% 1/10 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Stomatitis	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	9.1% 1/11 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Vomiting	8.3% 1/12 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	10.0% 1/10 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
General disorders Complication associated with device	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
General disorders Sudden death	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Infections and infestations Lung infection	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	10.0% 1/10 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Infections and infestations Respiratory tract infection	8.3% 1/12 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Investigations Neutrophil count decreased	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Metabolism and nutrition disorders Hypokalaemia	8.3% 1/12 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	10.0% 1/10 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Renal and urinary disorders Acute kidney injury	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	27.3% 3/11 • Number of events 3 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Vascular disorders Embolism	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Vascular disorders Hypotension	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.

Other adverse events
Measure	RRx-001 Pre-Treatment Plus SOC n=12 participants at risk Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC (four doses total). No additional RRx-001 will be given during the course of RT/cisplatin RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	RRx-001 Pre-Treatment, 2 Concurrent Doses Plus SOC n=11 participants at risk Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day in each of weeks 2 and 5 during RT/cisplatin administration RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	RRx-001 Pre-Treatment, 6 Concurrent Doses Plus SOC n=13 participants at risk Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day of each of the first 6 weeks during RT/cisplatin administration RRx-001: RRx-001 for injection Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study	Standard of Care n=10 participants at risk No doses of RRx-001 will be administered. Patients assigned to this arm will receive only standard of care in the form of a 7-week course of fractionated radiation therapy concurrent with a high-dose cisplatin regimen (100 mg/m2 dose in each of RT weeks 1, 4, and 7). Cisplatin for injection: Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients Radiation Therapy: Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study
Blood and lymphatic system disorders Anemia	8.3% 1/12 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	9.1% 1/11 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	10.0% 1/10 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Blood and lymphatic system disorders Febrile neutropenia	8.3% 1/12 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	9.1% 1/11 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Cardiac disorders Atrial fibrillation	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	10.0% 1/10 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Ear and labyrinth disorders Deafness	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	9.1% 1/11 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Ear and labyrinth disorders Hypoacusis	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	9.1% 1/11 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Colitis	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	9.1% 1/11 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Dry Mouth	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Dysphagia	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	9.1% 1/11 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	30.8% 4/13 • Number of events 4 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	40.0% 4/10 • Number of events 4 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Gastric perforation	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Nausea	8.3% 1/12 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	9.1% 1/11 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	20.0% 2/10 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Oral dysesthesia	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	20.0% 2/10 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Oral pain	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	9.1% 1/11 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	10.0% 1/10 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Salivary duct inflammation	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	10.0% 1/10 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Stomatitis	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	9.1% 1/11 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Gastrointestinal disorders Vomiting	8.3% 1/12 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	20.0% 2/10 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
General disorders Complication associated with device	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
General disorders Device related thrombosis	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	9.1% 1/11 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Infections and infestations Candida infection	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	9.1% 1/11 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Infections and infestations Lung infection	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	10.0% 1/10 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Infections and infestations Respiratory tract infection	8.3% 1/12 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Investigations Alanine aminotransferase increased	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	9.1% 1/11 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Investigations Blood creatinine increased	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	9.1% 1/11 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Investigations Lymphocyte count decreased	16.7% 2/12 • Number of events 4 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	45.5% 5/11 • Number of events 8 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	30.8% 4/13 • Number of events 7 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	30.0% 3/10 • Number of events 4 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Investigations Neutrophil count decreased	8.3% 1/12 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	27.3% 3/11 • Number of events 3 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	30.8% 4/13 • Number of events 4 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Investigations Weight decreased	8.3% 1/12 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Investigations White blood cell count decreased	16.7% 2/12 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	36.4% 4/11 • Number of events 4 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	15.4% 2/13 • Number of events 4 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	10.0% 1/10 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Metabolism and nutrition disorders Decreased appetite	8.3% 1/12 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	9.1% 1/11 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	15.4% 2/13 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Metabolism and nutrition disorders Hypokalaemia	8.3% 1/12 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	9.1% 1/11 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	9.1% 1/11 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	10.0% 1/10 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Flank pain	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	9.1% 1/11 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Nervous system disorders Dysgeusia	8.3% 1/12 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Renal and urinary disorders Acute kidney injury	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	18.2% 2/11 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	9.1% 1/11 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	16.7% 2/12 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	9.1% 1/11 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	20.0% 2/10 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Respiratory, thoracic and mediastinal disorders Swelling face	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Vascular disorders Embolism	0.00% 0/12 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	7.7% 1/13 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/10 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.
Vascular disorders Hypertension	8.3% 1/12 • Number of events 1 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/11 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	0.00% 0/13 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.	20.0% 2/10 • Number of events 2 • Adverse Events were collected beginning at baseline through end of treatment (12 weeks). All-Cause Mortality was assessed up to 12 weeks. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 is used to grade adverse events.