Trial Outcomes & Findings for Stereotactic Ablative Radiotherapy for Early-stage Glottic Larynx Cancer (NCT NCT03548285)

NCT ID: NCT03548285

Last Updated: 2025-05-22

Results Overview

Local failure is defined as biopsy-proven tumor anywhere on the true vocal cords.

Recruitment status

COMPLETED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

2 years

Results posted on

2025-05-22

Participant Flow

Participant milestones

Participant milestones
Measure	Patients Receiving SBRT Treatment Radiation therapy: Stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy (SBRT) Early-stage larynx cancer patients; all patients received SBRT (study treatment) at one of two different dose levels based on cohort (determined by whether the patient was low or moderate risk). The treatment fields are identical in both cohorts, and are expected to have the same patterns-of-failure. The dosing of these patients is not experimental and therefore was not a factor in analysis: all patients were analyzed together, as all received the same experimental treatment (SBRT). The biologically effective dose of this regimen is identical according to EQD2 (equivalent dose in 2 Gray fractions) analysis; in 5 fractions, the dose was equivalent to 65.52 Gy, and in 16 fractions, the dose was equivalent to 65.28 Gy. Therefore the biological impact of both regimens was the same, and this equivalence is why we analyzed the AE's together. The only potential difference between these dosing regimens is in late effects (1 year and after), but we saw no grade 2 or higher adverse events in either cohort, eliminating the need to report out late adverse events separately.
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stereotactic Ablative Radiotherapy for Early-stage Glottic Larynx Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Receiving SBRT n=25 Participants All patients on the clinical trial are receiving SBRT. Early-stage larynx cancer patients; all patients received SBRT (study treatment) at one of two different dose levels based on cohort (determined by whether the patient was low or moderate risk). The treatment fields are identical in both cohorts, and are expected to have the same patterns-of-failure. The dosing of these patients is not experimental and therefore was not a factor in analysis: all patients were analyzed together, as all received the same experimental treatment (SBRT). The biologically effective dose of this regimen is identical according to EQD2 (equivalent dose in 2 Gray fractions) analysis; in 5 fractions, the dose was equivalent to 65.52 Gy, and in 16 fractions, the dose was equivalent to 65.28 Gy. Therefore the biological impact of both regimens was the same, and this equivalence is why we analyzed the AE's together. The only potential difference between these dosing regimens is in late effects (1 year and after), but we saw no grade 2 or higher adverse events in either cohort, eliminating the need to report out late adverse events separately.
Age, Customized Age of patients	72 years n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	24 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	3 Participants n=99 Participants
Race (NIH/OMB) White	19 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants
Smoking None	8 participants n=99 Participants
Smoking Previous	16 participants n=99 Participants
Smoking Active	1 participants n=99 Participants

PRIMARY outcome

Timeframe: 2 years

Local failure is defined as biopsy-proven tumor anywhere on the true vocal cords.

Outcome measures

Outcome measures
Measure	All Patients n=25 Participants All patients on the clinical trial.	6M Follow up Six month follow up timepoint	12M Follow up Twelve month follow up timepoint	24M Follow Up Twenty-four month follow up timepoint	Baseline Baseline Timepoint
Number of Patients With Local Failure Following SABR Treatment of Early Glottic Larynx Cancers	2 participants	—	—	—	—

SECONDARY outcome

Timeframe: From baseline to 2 years post-treatment

Population: Participants who were able and willing to fill out PROs

Voice Handicap Index (VHI) voice-quality score to monitor changes in self-perception of voice handicap before and after treatment. 0-30 Mild Minimal amount of handicap 31-60 Moderate handicap 60-120 Severe handicap

Outcome measures

Outcome measures
Measure	All Patients n=22 Participants All patients on the clinical trial.	6M Follow up n=18 Participants Six month follow up timepoint	12M Follow up n=18 Participants Twelve month follow up timepoint	24M Follow Up n=11 Participants Twenty-four month follow up timepoint	Baseline n=21 Participants Baseline Timepoint
Voice-quality Score Following Treatment With SABR	28.5 score on a scale Interval 8.0 to 48.0	4 score on a scale Interval 0.0 to 12.0	7.5 score on a scale Interval 0.0 to 12.0	7.5 score on a scale Interval 0.0 to 12.0	57 score on a scale Interval 32.0 to 69.0

SECONDARY outcome

Timeframe: 90 days, 3 years

Number of patients with grade 3-5 acute (start of treatment through 90 days from the completion of treatment) and late (after 90 days from the completion of treatment) adverse events, according to NCI's Common Terminology Criteria for Adverse Events (CTCAE) v4.0 toxicity criteria.

Outcome measures

Outcome measures
Measure	All Patients n=25 Participants All patients on the clinical trial.	6M Follow up Six month follow up timepoint	12M Follow up Twelve month follow up timepoint	24M Follow Up Twenty-four month follow up timepoint	Baseline Baseline Timepoint
Number of Patients With Grade 3-5 Acute and Late Toxicities Following Treatment With SABR Acute	6 participants	—	—	—	—
Number of Patients With Grade 3-5 Acute and Late Toxicities Following Treatment With SABR Late	19 participants	—	—	—	—

SECONDARY outcome

Timeframe: From baseline to 2 years post-treatment

Average patient visual analogue scale score (derived from EQ-5D) at baseline, 6, 12, and 24 months from the end of treatment The Visual Analogue Score (VAS) of the EQ-5D is a visual scale from 0-100, with 100 being perfect health, where patients can mark their perceived health. Researchers can then take the average score across all patients for each timepoint.

Outcome measures

Outcome measures
Measure	All Patients n=25 Participants All patients on the clinical trial.	6M Follow up Six month follow up timepoint	12M Follow up Twelve month follow up timepoint	24M Follow Up Twenty-four month follow up timepoint	Baseline Baseline Timepoint
Health-related Quality of Life Following Treatment With SABR. 12 Months	83.2 score on a scale Interval 0.0 to 100.0	—	—	—	—
Health-related Quality of Life Following Treatment With SABR. 24 Months	85.5 score on a scale Interval 0.0 to 100.0	—	—	—	—
Health-related Quality of Life Following Treatment With SABR. Baseline	78 score on a scale Interval 0.0 to 100.0	—	—	—	—
Health-related Quality of Life Following Treatment With SABR. 6 Months	86.2 score on a scale Interval 0.0 to 100.0	—	—	—	—

SECONDARY outcome

Timeframe: 2 years

Specifically, the 2-year cumulative risk of biopsy-proven recurrence anywhere in the larynx or neck following SABR. Recurrence in this context includes biopsy-proven cancer anywhere in the supraglottic, glottic, or subglottic larynx, as well as any malignant lymph node in the cervical or supraclavicular lymph nodes.

Outcome measures

Outcome measures
Measure	All Patients n=25 Participants All patients on the clinical trial.	6M Follow up Six month follow up timepoint	12M Follow up Twelve month follow up timepoint	24M Follow Up Twenty-four month follow up timepoint	Baseline Baseline Timepoint
Percentage of Participants With Locoregional Failure Following SABR With Death as a Competing Risk 2 Years	8 Percentage of participants Interval 3.0 to 24.0	—	—	—	—
Percentage of Participants With Locoregional Failure Following SABR With Death as a Competing Risk 1 Year	4 Percentage of participants Interval 0.8 to 20.0	—	—	—	—

SECONDARY outcome

Timeframe: 2 years

Overall survival

Outcome measures

Outcome measures
Measure	All Patients n=25 Participants All patients on the clinical trial.	6M Follow up Six month follow up timepoint	12M Follow up Twelve month follow up timepoint	24M Follow Up Twenty-four month follow up timepoint	Baseline Baseline Timepoint
Overall Survival Passed	4 patients	—	—	—	—
Overall Survival Survival	21 patients	—	—	—	—

SECONDARY outcome

Timeframe: 2 years

With death and prior locoregional failure as competing risks

Outcome measures

Outcome measures
Measure	All Patients n=25 Participants All patients on the clinical trial.	6M Follow up Six month follow up timepoint	12M Follow up Twelve month follow up timepoint	24M Follow Up Twenty-four month follow up timepoint	Baseline Baseline Timepoint
Percentage of Patient Population With Regional Failure and Distant Metastasis 2-year regional recurrence	8 Percentage of participants	—	—	—	—
Percentage of Patient Population With Regional Failure and Distant Metastasis 2-year distant metastasis	8 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 2 years

Laryngectomy-free survival probability at 2 years

Outcome measures

Outcome measures
Measure	All Patients n=25 Participants All patients on the clinical trial.	6M Follow up Six month follow up timepoint	12M Follow up Twelve month follow up timepoint	24M Follow Up Twenty-four month follow up timepoint	Baseline Baseline Timepoint
Laryngectomy-free Survival	88 Percentage of patients with LFS at 2 yrs	—	—	—	—

Adverse Events

All Patients

Serious events: 2 serious events

Other events: 25 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	All Patients n=25 participants at risk All patients on the clinical trial.
Renal and urinary disorders Acute kidney injury	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Respiratory, thoracic and mediastinal disorders Aspiration	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Renal and urinary disorders Chronic kidney disease	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Metabolism and nutrition disorders Dehydration	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Gastrointestinal disorders Dysphagia	4.0% 1/25 • Number of events 2 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Gastrointestinal disorders Gastroenteritis	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Metabolism and nutrition disorders Hypoglycemia	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Metabolism and nutrition disorders Hyponatremia	8.0% 2/25 • Number of events 2 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Investigations INR Increased	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Infections and infestations Lung infection	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Respiratory, thoracic and mediastinal disorders Productive cough	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Respiratory, thoracic and mediastinal disorders Hypoxic respiratory failure	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Infections and infestations Skin infection	4.0% 1/25 • Number of events 2 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.

Other adverse events

Other adverse events
Measure	All Patients n=25 participants at risk All patients on the clinical trial.
Gastrointestinal disorders Abdominal pain	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	16.0% 4/25 • Number of events 4 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Metabolism and nutrition disorders Anorexia	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Psychiatric disorders Anxiety	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Musculoskeletal and connective tissue disorders Arthralgia	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Cardiac disorders Atrial flutter	4.0% 1/25 • Number of events 5 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Eye disorders Blurred vision	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Infections and infestations Bronchial infection	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Cardiac disorders Bradycardia	8.0% 2/25 • Number of events 4 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Gastrointestinal disorders constipation	24.0% 6/25 • Number of events 7 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Respiratory, thoracic and mediastinal disorders Cough	32.0% 8/25 • Number of events 9 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Investigations Creatinine increased	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Psychiatric disorders Depression	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Injury, poisoning and procedural complications Dermatitis radiation	8.0% 2/25 • Number of events 2 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Gastrointestinal disorders diarrhea	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Nervous system disorders Dizziness	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Gastrointestinal disorders Dry mouth	36.0% 9/25 • Number of events 13 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Respiratory, thoracic and mediastinal disorders Dry throat	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Nervous system disorders Dysesthesia	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Nervous system disorders Dysgeusia	32.0% 8/25 • Number of events 8 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Gastrointestinal disorders Dysphagia	24.0% 6/25 • Number of events 9 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.0% 2/25 • Number of events 2 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Ear and labyrinth disorders Ear pain	12.0% 3/25 • Number of events 3 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
General disorders Edema	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
General disorders Edema limb	16.0% 4/25 • Number of events 4 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Injury, poisoning and procedural complications Fall	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
General disorders Fatigue	36.0% 9/25 • Number of events 9 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
General disorders Fever	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Gastrointestinal disorders Gastroesophageal reflux disease	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Gastrointestinal disorders Odynophagia	20.0% 5/25 • Number of events 5 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Gastrointestinal disorders Mucus Production	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
General disorders Voice fatigue	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Gastrointestinal disorders Black stool	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Nervous system disorders Headaches	8.0% 2/25 • Number of events 2 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Renal and urinary disorders Hematuria	4.0% 1/25 • Number of events 2 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Respiratory, thoracic and mediastinal disorders Hoarseness	48.0% 12/25 • Number of events 17 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Metabolism and nutrition disorders hypercalcemia	4.0% 1/25 • Number of events 2 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Vascular disorders Hypertension	68.0% 17/25 • Number of events 57 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Metabolism and nutrition disorders Hypoglycemia	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Metabolism and nutrition disorders Hyponatremia	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Vascular disorders hypotension	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Infections and infestations Ear infection	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Infections and infestations Covid-19	16.0% 4/25 • Number of events 4 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Infections and infestations oral thrush	8.0% 2/25 • Number of events 2 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Injury, poisoning and procedural complications Cartilage tear (L ankle)	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Injury, poisoning and procedural complications Suprapubic catheter dysfunction	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Injury, poisoning and procedural complications torn meniscus L knee	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Psychiatric disorders Insomnia	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Respiratory, thoracic and mediastinal disorders Laryngeal edema	16.0% 4/25 • Number of events 4 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Respiratory, thoracic and mediastinal disorders Laryngeal mucositis	16.0% 4/25 • Number of events 4 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of prostate	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Metabolism and nutrition disorders type II diabetes	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Infections and infestations Mucosal infection	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Gastrointestinal disorders Mucositis oral	16.0% 4/25 • Number of events 4 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Musculoskeletal and connective tissue disorders hip pain	8.0% 2/25 • Number of events 2 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Respiratory, thoracic and mediastinal disorders nasal congestion	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Gastrointestinal disorders nausea	8.0% 2/25 • Number of events 2 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
General disorders Neck edema	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Musculoskeletal and connective tissue disorders neck pain	8.0% 2/25 • Number of events 2 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) polyp	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Gastrointestinal disorders Oral pain	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
General disorders Pain	4.0% 1/25 • Number of events 2 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Musculoskeletal and connective tissue disorders Pain in extremity	8.0% 2/25 • Number of events 3 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Respiratory, thoracic and mediastinal disorders Postnasal drip	8.0% 2/25 • Number of events 2 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Respiratory, thoracic and mediastinal disorders Productive cough	20.0% 5/25 • Number of events 5 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Renal and urinary disorders urethral stricture	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Respiratory, thoracic and mediastinal disorders COPD	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Gastrointestinal disorders Salivary duct inflammation	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Infections and infestations Sinusitis	4.0% 1/25 • Number of events 2 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Skin and subcutaneous tissue disorders erythema in left arytenoid	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Skin and subcutaneous tissue disorders Scalp lesion	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Respiratory, thoracic and mediastinal disorders Sore throat	44.0% 11/25 • Number of events 15 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Surgical and medical procedures bladder prostate surgery	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Gastrointestinal disorders Thick secretions	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Ear and labyrinth disorders Tinnitus	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Infections and infestations Upper respiratory infection	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Renal and urinary disorders Urinary retention	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Infections and infestations Urinary tract infection	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Respiratory, thoracic and mediastinal disorders Vocal cord inflammation	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Respiratory, thoracic and mediastinal disorders Voice alteration	12.0% 3/25 • Number of events 3 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Investigations Weight gain	4.0% 1/25 • Number of events 1 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.
Investigations Weight loss	16.0% 4/25 • Number of events 6 • From baseline to 36M post treatment Adverse events were not collected separately based on dose. The AEs were evaluated with all patients together as one group.

Additional Information

David Sher, MD

University of Texas Southwestern Medical Center

Phone: 214-645-8525

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place