Trial Outcomes & Findings for Hypofractionated Adjuvant Radiotherapy for Resected Head and Neck Cancers (NCT NCT05120947)
NCT ID: NCT05120947
Last Updated: 2026-05-01
Results Overview
This measure is the number of subjects experiencing a dose-limiting toxicity. A dose-limiting toxicity is defined as an inability to complete radiation treatment within 30 days of the start of radiotherapy that is not deemed to be related to disease progression; OR an unacceptable toxicity within one year of treatment (Grade 4+ toxicity) that is probably or definitely related to radiation treatment as determined by the treating physician or a death within one year of treatment that is probably or definitely related to treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
12 months
Results posted on
2026-05-01
Participant Flow
Participant milestones
| Measure |
42 Gray (Gy) Radiation
42 gy of radiation therapy will be administered in 10 fractions.
42 Gy Radiation Therapy: Radiation Therapy: Dose per fraction of 4.2 Gy.
|
39 Gray (Gy) Radiation
39 gy of radiation therapy will be administered in 8 fractions.
39 Gy Radiation Therapy: Radiation Therapy: Dose per fraction of 4.875 Gy.
|
32.5 Gray (Gy) Radiation
32.5 gy of radiation therapy will be administered in 5 fractions.
32.5 Gy Radiation Therapy: Radiation Therapy: Dose per fraction of 6.5 Gy.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
11
|
|
Overall Study
COMPLETED
|
3
|
3
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hypofractionated Adjuvant Radiotherapy for Resected Head and Neck Cancers
Baseline characteristics by cohort
| Measure |
42 Gray (Gy) Radiation
n=3 Participants
42 gy of radiation therapy will be administered in 10 fractions.
42 Gy Radiation Therapy: Radiation Therapy: Dose per fraction of 4.2 Gy.
|
39 Gray (Gy) Radiation
n=4 Participants
39 gy of radiation therapy will be administered in 8 fractions.
39 Gy Radiation Therapy: Radiation Therapy: Dose per fraction of 4.875 Gy.
|
32.5 Gray (Gy) Radiation
n=11 Participants
32.5 gy of radiation therapy will be administered in 5 fractions.
32.5 Gy Radiation Therapy: Radiation Therapy: Dose per fraction of 6.5 Gy.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=14 Participants
|
2 Participants
n=34 Participants
|
3 Participants
n=69 Participants
|
6 Participants
n=140 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=14 Participants
|
2 Participants
n=34 Participants
|
8 Participants
n=69 Participants
|
12 Participants
n=140 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=14 Participants
|
3 Participants
n=34 Participants
|
4 Participants
n=69 Participants
|
8 Participants
n=140 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
7 Participants
n=69 Participants
|
10 Participants
n=140 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=14 Participants
|
4 Participants
n=34 Participants
|
11 Participants
n=69 Participants
|
18 Participants
n=140 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=14 Participants
|
4 Participants
n=34 Participants
|
11 Participants
n=69 Participants
|
18 Participants
n=140 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=14 Participants
|
4 participants
n=34 Participants
|
11 participants
n=69 Participants
|
18 participants
n=140 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThis will be determined as the radiation dose with the minimum number of fractions at which there is no more than a 33% rate of dose-limiting toxicity (DLT) up to 12 months after completion of radiation treatment using the TITE-CRM design.
Outcome measures
| Measure |
39 Gray (Gy) Radiation
39 gy of radiation therapy will be administered in 8 fractions.
39 Gy Radiation Therapy: Radiation Therapy: Dose per fraction of 4.875 Gy.
|
32.5 Gray (Gy) Radiation
32.5 gy of radiation therapy will be administered in 5 fractions.
32.5 Gy Radiation Therapy: Radiation Therapy: Dose per fraction of 6.5 Gy.
|
Maximum Tolerated Dose
n=17 Participants
This will be determined as the radiation dose with the minimum number of fractions at which there is no more than a 33% rate of dose-limiting toxicity (DLT) up to 12 months after completion of radiation treatment using the TITE-CRM design.
|
|---|---|---|---|
|
Maximum-tolerated Radiation Dose
|
—
|
—
|
32.5 Gy
|
PRIMARY outcome
Timeframe: 12 monthsThis measure is the number of subjects experiencing a dose-limiting toxicity. A dose-limiting toxicity is defined as an inability to complete radiation treatment within 30 days of the start of radiotherapy that is not deemed to be related to disease progression; OR an unacceptable toxicity within one year of treatment (Grade 4+ toxicity) that is probably or definitely related to radiation treatment as determined by the treating physician or a death within one year of treatment that is probably or definitely related to treatment.
Outcome measures
| Measure |
39 Gray (Gy) Radiation
n=3 Participants
39 gy of radiation therapy will be administered in 8 fractions.
39 Gy Radiation Therapy: Radiation Therapy: Dose per fraction of 4.875 Gy.
|
32.5 Gray (Gy) Radiation
n=11 Participants
32.5 gy of radiation therapy will be administered in 5 fractions.
32.5 Gy Radiation Therapy: Radiation Therapy: Dose per fraction of 6.5 Gy.
|
Maximum Tolerated Dose
n=3 Participants
This will be determined as the radiation dose with the minimum number of fractions at which there is no more than a 33% rate of dose-limiting toxicity (DLT) up to 12 months after completion of radiation treatment using the TITE-CRM design.
|
|---|---|---|---|
|
Incidence of Dose-Limiting Toxicities
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: One yearThis measure is the number of subjects alive at one year following the conclusion of scheduled radiation therapy.
Outcome measures
| Measure |
39 Gray (Gy) Radiation
n=3 Participants
39 gy of radiation therapy will be administered in 8 fractions.
39 Gy Radiation Therapy: Radiation Therapy: Dose per fraction of 4.875 Gy.
|
32.5 Gray (Gy) Radiation
n=11 Participants
32.5 gy of radiation therapy will be administered in 5 fractions.
32.5 Gy Radiation Therapy: Radiation Therapy: Dose per fraction of 6.5 Gy.
|
Maximum Tolerated Dose
n=3 Participants
This will be determined as the radiation dose with the minimum number of fractions at which there is no more than a 33% rate of dose-limiting toxicity (DLT) up to 12 months after completion of radiation treatment using the TITE-CRM design.
|
|---|---|---|---|
|
Overall Survival
|
100 percentage of subjects surviving
|
81.8 percentage of subjects surviving
|
100 percentage of subjects surviving
|
SECONDARY outcome
Timeframe: One yearThis measure is the number of subjects showing disease progression in the head and neck by response evaluation criteria in solid tumors (RECIST) criteria.
Outcome measures
| Measure |
39 Gray (Gy) Radiation
n=3 Participants
39 gy of radiation therapy will be administered in 8 fractions.
39 Gy Radiation Therapy: Radiation Therapy: Dose per fraction of 4.875 Gy.
|
32.5 Gray (Gy) Radiation
n=11 Participants
32.5 gy of radiation therapy will be administered in 5 fractions.
32.5 Gy Radiation Therapy: Radiation Therapy: Dose per fraction of 6.5 Gy.
|
Maximum Tolerated Dose
n=3 Participants
This will be determined as the radiation dose with the minimum number of fractions at which there is no more than a 33% rate of dose-limiting toxicity (DLT) up to 12 months after completion of radiation treatment using the TITE-CRM design.
|
|---|---|---|---|
|
Locoregional Progression
|
0 percentage of subjects progressing
|
18.1 percentage of subjects progressing
|
0 percentage of subjects progressing
|
Adverse Events
42 Gray (Gy) Radiation
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
39 Gray (Gy) Radiation
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
32.5 Gray (Gy) Radiation
Serious events: 3 serious events
Other events: 11 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
42 Gray (Gy) Radiation
n=3 participants at risk
42 gy of radiation therapy will be administered in 10 fractions.
42 Gy Radiation Therapy: Radiation Therapy: Dose per fraction of 4.2 Gy.
|
39 Gray (Gy) Radiation
n=3 participants at risk
39 gy of radiation therapy will be administered in 8 fractions.
39 Gy Radiation Therapy: Radiation Therapy: Dose per fraction of 4.875 Gy.
|
32.5 Gray (Gy) Radiation
n=11 participants at risk
32.5 gy of radiation therapy will be administered in 5 fractions.
32.5 Gy Radiation Therapy: Radiation Therapy: Dose per fraction of 6.5 Gy.
|
|---|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
18.2%
2/11 • Number of events 2 • Up to 12 months.
|
|
Investigations
Weight Loss
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
Other adverse events
| Measure |
42 Gray (Gy) Radiation
n=3 participants at risk
42 gy of radiation therapy will be administered in 10 fractions.
42 Gy Radiation Therapy: Radiation Therapy: Dose per fraction of 4.2 Gy.
|
39 Gray (Gy) Radiation
n=3 participants at risk
39 gy of radiation therapy will be administered in 8 fractions.
39 Gy Radiation Therapy: Radiation Therapy: Dose per fraction of 4.875 Gy.
|
32.5 Gray (Gy) Radiation
n=11 participants at risk
32.5 gy of radiation therapy will be administered in 5 fractions.
32.5 Gy Radiation Therapy: Radiation Therapy: Dose per fraction of 6.5 Gy.
|
|---|---|---|---|
|
Renal and urinary disorders
stent infection
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Gastrointestinal disorders
swollen tongue
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
18.2%
2/11 • Number of events 2 • Up to 12 months.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Gastrointestinal disorders
Thick secretions
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
66.7%
2/3 • Number of events 2 • Up to 12 months.
|
27.3%
3/11 • Number of events 5 • Up to 12 months.
|
|
Gastrointestinal disorders
throat tightness
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Infections and infestations
Thrush
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
36.4%
4/11 • Number of events 8 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/3 • Up to 12 months.
|
66.7%
2/3 • Number of events 2 • Up to 12 months.
|
54.5%
6/11 • Number of events 6 • Up to 12 months.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Investigations
Weight loss
|
66.7%
2/3 • Number of events 4 • Up to 12 months.
|
100.0%
3/3 • Number of events 6 • Up to 12 months.
|
72.7%
8/11 • Number of events 13 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Up to 12 months.
|
66.7%
2/3 • Number of events 2 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Up to 12 months.
|
66.7%
2/3 • Number of events 3 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
General disorders
Fever
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Gastrointestinal disorders
loose teeth
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 2 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Endocrine disorders
Hypothyroidism
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Up to 12 months.
|
66.7%
2/3 • Number of events 2 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
100.0%
3/3 • Number of events 5 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Gastrointestinal disorders
Pressure callous inside mouth
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Skin and subcutaneous tissue disorders
pressure ulcer
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
66.7%
2/3 • Number of events 2 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
tailbone pain
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 2 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 2 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Infections and infestations
COVID-19 Infection
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Ear and labyrinth disorders
Impacted Cerumen of right ear
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
General disorders
Gait disturbance
|
33.3%
1/3 • Number of events 2 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Eye disorders
Glaucoma
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
33.3%
1/3 • Number of events 2 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
New Thyroid Nodules
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Infections and infestations
Penile infection
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Eye disorders
Retinopathy
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Injury, poisoning and procedural complications
Seroma
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Skin and subcutaneous tissue disorders
Basal cell carcinoma
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Gastrointestinal disorders
Tonsillar Hypertrophy
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/11 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
18.2%
2/11 • Number of events 3 • Up to 12 months.
|
|
General disorders
Edema face
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
66.7%
2/3 • Number of events 3 • Up to 12 months.
|
36.4%
4/11 • Number of events 4 • Up to 12 months.
|
|
General disorders
Edema limbs
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
18.2%
2/11 • Number of events 2 • Up to 12 months.
|
|
General disorders
Edema trunk
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 2 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
General disorders
Facial pain
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 6 • Up to 12 months.
|
100.0%
3/3 • Number of events 3 • Up to 12 months.
|
72.7%
8/11 • Number of events 9 • Up to 12 months.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Vascular disorders
Hypertension
|
66.7%
2/3 • Number of events 2 • Up to 12 months.
|
66.7%
2/3 • Number of events 3 • Up to 12 months.
|
27.3%
3/11 • Number of events 7 • Up to 12 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
18.2%
2/11 • Number of events 2 • Up to 12 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Investigations
INR increased
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Left hip pain
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
General disorders
Localized edema
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
18.2%
2/11 • Number of events 3 • Up to 12 months.
|
|
Vascular disorders
Lymphedema
|
66.7%
2/3 • Number of events 2 • Up to 12 months.
|
66.7%
2/3 • Number of events 2 • Up to 12 months.
|
72.7%
8/11 • Number of events 9 • Up to 12 months.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
18.2%
2/11 • Number of events 2 • Up to 12 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
100.0%
3/3 • Number of events 9 • Up to 12 months.
|
100.0%
3/3 • Number of events 7 • Up to 12 months.
|
100.0%
11/11 • Number of events 27 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
L fibula skin graft - leg wound
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2 • Up to 12 months.
|
100.0%
3/3 • Number of events 4 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
General disorders
Neck edema
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
100.0%
3/3 • Number of events 5 • Up to 12 months.
|
18.2%
2/11 • Number of events 3 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
36.4%
4/11 • Number of events 4 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Neck stiffness
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 2 • Up to 12 months.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 2 • Up to 12 months.
|
|
Gastrointestinal disorders
Oral pain
|
100.0%
3/3 • Number of events 3 • Up to 12 months.
|
100.0%
3/3 • Number of events 5 • Up to 12 months.
|
45.5%
5/11 • Number of events 12 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
General disorders
Pain
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Nervous system disorders
Paresthesia
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
18.2%
2/11 • Number of events 2 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Gastrointestinal disorders
polydipsia
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 3 • Up to 12 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 2 • Up to 12 months.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
100.0%
3/3 • Number of events 4 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
54.5%
6/11 • Number of events 7 • Up to 12 months.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
18.2%
2/11 • Number of events 2 • Up to 12 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to 12 months.
|
66.7%
2/3 • Number of events 2 • Up to 12 months.
|
18.2%
2/11 • Number of events 2 • Up to 12 months.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Gastrointestinal disorders
Dry mouth
|
100.0%
3/3 • Number of events 4 • Up to 12 months.
|
100.0%
3/3 • Number of events 4 • Up to 12 months.
|
81.8%
9/11 • Number of events 12 • Up to 12 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
66.7%
2/3 • Number of events 2 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Nervous system disorders
Dysarthria
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Nervous system disorders
Dysgeusia
|
66.7%
2/3 • Number of events 4 • Up to 12 months.
|
66.7%
2/3 • Number of events 2 • Up to 12 months.
|
81.8%
9/11 • Number of events 12 • Up to 12 months.
|
|
Gastrointestinal disorders
Dysphagia
|
100.0%
3/3 • Number of events 8 • Up to 12 months.
|
66.7%
2/3 • Number of events 6 • Up to 12 months.
|
100.0%
11/11 • Number of events 18 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
18.2%
2/11 • Number of events 2 • Up to 12 months.
|
|
Gastrointestinal disorders
Bleeding tongue
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Eye disorders
cellulitis
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Number of events 3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
45.5%
5/11 • Number of events 5 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
18.2%
2/11 • Number of events 3 • Up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
coughing blood
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 2 • Up to 12 months.
|
|
Eye disorders
crusting of both eyes
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
66.7%
2/3 • Number of events 3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
72.7%
8/11 • Number of events 10 • Up to 12 months.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • Up to 12 months.
|
0.00%
0/3 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
100.0%
3/3 • Number of events 3 • Up to 12 months.
|
100.0%
3/3 • Number of events 3 • Up to 12 months.
|
45.5%
5/11 • Number of events 6 • Up to 12 months.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 3 • Up to 12 months.
|
66.7%
2/3 • Number of events 3 • Up to 12 months.
|
36.4%
4/11 • Number of events 5 • Up to 12 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Up to 12 months.
|
66.7%
2/3 • Number of events 4 • Up to 12 months.
|
45.5%
5/11 • Number of events 8 • Up to 12 months.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Up to 12 months.
|
33.3%
1/3 • Number of events 1 • Up to 12 months.
|
9.1%
1/11 • Number of events 1 • Up to 12 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place