Trial Outcomes & Findings for Margin-Based Vs. Robust Photon Radiotherapy Planning in IMRT of HN-SQCC (NCT NCT03552965)
NCT ID: NCT03552965
Last Updated: 2025-09-02
Results Overview
Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 "occasional dryness" through Stage 4 "complete dryness, debilitating". Lower stage values indicate a more favorable outcome than higher stage values.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Baseline
Results posted on
2025-09-02
Participant Flow
Participant milestones
| Measure |
Margin-Based Radiotherapy Planning
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area.
Margin-Based Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area
|
Robust Radiotherapy Planning
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue.
Robust Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
13
|
|
Overall Study
COMPLETED
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Margin-Based Radiotherapy Planning
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area.
Margin-Based Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area
|
Robust Radiotherapy Planning
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue.
Robust Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Continuation not in patient best interest
|
1
|
0
|
|
Overall Study
Patient opted to be treated elsewhere
|
1
|
0
|
Baseline Characteristics
Margin-Based Vs. Robust Photon Radiotherapy Planning in IMRT of HN-SQCC
Baseline characteristics by cohort
| Measure |
Margin-Based Radiotherapy Planning
n=10 Participants
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area.
Margin-Based Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area
|
Robust Radiotherapy Planning
n=13 Participants
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue.
Robust Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.9615 years
STANDARD_DEVIATION 9.37823 • n=5 Participants
|
62.8215 years
STANDARD_DEVIATION 11.87871 • n=7 Participants
|
62.8824 years
STANDARD_DEVIATION 10.62783 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
13 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic scale (LENT-SOMA)
|
1.14 units on a scale
STANDARD_DEVIATION 0.378 • n=5 Participants
|
1.17 units on a scale
STANDARD_DEVIATION 0.577 • n=7 Participants
|
1.16 units on a scale
STANDARD_DEVIATION 0.501 • n=5 Participants
|
|
University of Michigan's Xerostomia Questionnaire (XQ)
|
15.5 score on a scale
STANDARD_DEVIATION 23.76242 • n=5 Participants
|
14.1346 score on a scale
STANDARD_DEVIATION 17.87095 • n=7 Participants
|
14.7283 score on a scale
STANDARD_DEVIATION 20.14139 • n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: There were missing data.
Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 "occasional dryness" through Stage 4 "complete dryness, debilitating". Lower stage values indicate a more favorable outcome than higher stage values.
Outcome measures
| Measure |
Margin-Based Radiotherapy Planning
n=7 Participants
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area.
Margin-Based Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area
|
Robust Radiotherapy Planning
n=12 Participants
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue.
Robust Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue
|
|---|---|---|
|
Grade of Xerostomia
|
1.14 units on a scale
Standard Deviation 0.378
|
1.17 units on a scale
Standard Deviation 0.577
|
PRIMARY outcome
Timeframe: Month 3 (i.e., 3 months (+/- 30 days) after baseline visit)Population: There were missing data.
Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 "occasional dryness" through Stage 4 "complete dryness, debilitating". Lower stage values indicate a more favorable outcome than higher stage values.
Outcome measures
| Measure |
Margin-Based Radiotherapy Planning
n=6 Participants
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area.
Margin-Based Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area
|
Robust Radiotherapy Planning
n=11 Participants
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue.
Robust Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue
|
|---|---|---|
|
Grade of Xerostomia
|
2.00 units on a scale
Standard Deviation 0.894
|
2.91 units on a scale
Standard Deviation 1.136
|
PRIMARY outcome
Timeframe: Month 6 (i.e., 6 months (+/- 30 days) after baseline visit)Population: There were missing data.
Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 "occasional dryness" through Stage 4 "complete dryness, debilitating". Lower stage values indicate a more favorable outcome than higher stage values.
Outcome measures
| Measure |
Margin-Based Radiotherapy Planning
n=4 Participants
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area.
Margin-Based Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area
|
Robust Radiotherapy Planning
n=9 Participants
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue.
Robust Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue
|
|---|---|---|
|
Grade of Xerostomia
|
2.5 units on a scale
Standard Deviation 0.577
|
2.33 units on a scale
Standard Deviation 1.225
|
PRIMARY outcome
Timeframe: Month 9 (i.e., 9 months (+/- 30 days) after baseline visit)Population: There were missing data.
Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 "occasional dryness" through Stage 4 "complete dryness, debilitating". Lower stage values indicate a more favorable outcome than higher stage values.
Outcome measures
| Measure |
Margin-Based Radiotherapy Planning
n=6 Participants
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area.
Margin-Based Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area
|
Robust Radiotherapy Planning
n=9 Participants
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue.
Robust Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue
|
|---|---|---|
|
Grade of Xerostomia
|
1.83 units on a scale
Standard Deviation 0.753
|
2.33 units on a scale
Standard Deviation 1.000
|
PRIMARY outcome
Timeframe: Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)Population: There were missing data.
Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 "occasional dryness" through Stage 4 "complete dryness, debilitating". Lower stage values indicate a more favorable outcome than higher stage values.
Outcome measures
| Measure |
Margin-Based Radiotherapy Planning
n=5 Participants
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area.
Margin-Based Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area
|
Robust Radiotherapy Planning
n=8 Participants
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue.
Robust Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue
|
|---|---|---|
|
Grade of Xerostomia
|
2.00 units on a scale
Standard Deviation 0.707
|
2.38 units on a scale
Standard Deviation 1.188
|
PRIMARY outcome
Timeframe: BaselineSelf reported dry mouth using University of Michigan's Xerostomia Questionnaire (XQ). This questionnaire has 8 questions that measure the degree to which xerostomia is affecting quality of life. Patients rate each item on a scale from 0 to 10. Higher score denotes worse xerostomia. To analyze the XQ, scores on its 8 items will be summed for each subject at each time point to produce an overall XQ score whose values theoretically can range from 0 to 80; it will be treated as a continuous variable. Lower values indicate a more favorable outcome than higher values.
Outcome measures
| Measure |
Margin-Based Radiotherapy Planning
n=10 Participants
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area.
Margin-Based Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area
|
Robust Radiotherapy Planning
n=13 Participants
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue.
Robust Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue
|
|---|---|---|
|
Prevalence of Xerostomia
|
15.5 score on a scale
Standard Deviation 23.76242
|
14.1346 score on a scale
Standard Deviation 17.87095
|
PRIMARY outcome
Timeframe: Month 3 (i.e., 3 months (+/- 30 days) after baseline visit)Population: There were missing data.
Self reported dry mouth using University of Michigan's Xerostomia Questionnaire (XQ). This questionnaire has 8 questions that measure the degree to which xerostomia is affecting quality of life. Patients rate each item on a scale from 0 to 10. Higher score denotes worse xerostomia. To analyze the XQ, scores on its 8 items will be summed for each subject at each time point to produce an overall XQ score whose values theoretically can range from 0 to 80; it will be treated as a continuous variable. Lower values indicate a more favorable outcome than higher values.
Outcome measures
| Measure |
Margin-Based Radiotherapy Planning
n=6 Participants
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area.
Margin-Based Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area
|
Robust Radiotherapy Planning
n=11 Participants
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue.
Robust Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue
|
|---|---|---|
|
Prevalence of Xerostomia
|
45.625 score on a scale
Standard Deviation 30.68744
|
64.3182 score on a scale
Standard Deviation 15.0142
|
PRIMARY outcome
Timeframe: Month 6 (i.e., 6 months (+/- 30 days) after baseline visit)Population: There were missing data.
Self reported dry mouth using University of Michigan's Xerostomia Questionnaire (XQ). This questionnaire has 8 questions that measure the degree to which xerostomia is affecting quality of life. Patients rate each item on a scale from 0 to 10. Higher score denotes worse xerostomia. To analyze the XQ, scores on its 8 items will be summed for each subject at each time point to produce an overall XQ score whose values theoretically can range from 0 to 80; it will be treated as a continuous variable. Lower values indicate a more favorable outcome than higher values.
Outcome measures
| Measure |
Margin-Based Radiotherapy Planning
n=5 Participants
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area.
Margin-Based Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area
|
Robust Radiotherapy Planning
n=9 Participants
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue.
Robust Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue
|
|---|---|---|
|
Prevalence of Xerostomia
|
60.0000 score on a scale
Standard Deviation 23.68412
|
54.8611 score on a scale
Standard Deviation 29.91815
|
PRIMARY outcome
Timeframe: Month 9 (i.e., 9 months (+/- 30 days) after baseline visit)Population: There were missing data.
Self reported dry mouth using University of Michigan's Xerostomia Questionnaire (XQ). This questionnaire has 8 questions that measure the degree to which xerostomia is affecting quality of life. Patients rate each item on a scale from 0 to 10. Higher score denotes worse xerostomia. To analyze the XQ, scores on its 8 items will be summed for each subject at each time point to produce an overall XQ score whose values theoretically can range from 0 to 80; it will be treated as a continuous variable. Lower values indicate a more favorable outcome than higher values.
Outcome measures
| Measure |
Margin-Based Radiotherapy Planning
n=6 Participants
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area.
Margin-Based Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area
|
Robust Radiotherapy Planning
n=9 Participants
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue.
Robust Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue
|
|---|---|---|
|
Prevalence of Xerostomia
|
31.6667 score on a scale
Standard Deviation 31.38139
|
54.0278 score on a scale
Standard Deviation 24.57274
|
PRIMARY outcome
Timeframe: Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)Population: There were missing data.
Self reported dry mouth using University of Michigan's Xerostomia Questionnaire (XQ). This questionnaire has 8 questions that measure the degree to which xerostomia is affecting quality of life. Patients rate each item on a scale from 0 to 10. Higher score denotes worse xerostomia. To analyze the XQ, scores on its 8 items will be summed for each subject at each time point to produce an overall XQ score whose values theoretically can range from 0 to 80; it will be treated as a continuous variable. Lower values indicate a more favorable outcome than higher values.
Outcome measures
| Measure |
Margin-Based Radiotherapy Planning
n=5 Participants
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area.
Margin-Based Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area
|
Robust Radiotherapy Planning
n=8 Participants
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue.
Robust Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue
|
|---|---|---|
|
Prevalence of Xerostomia
|
50.75 score on a scale
Standard Deviation 30.29284
|
38.4375 score on a scale
Standard Deviation 26.69897
|
Adverse Events
Margin-Based Radiotherapy Planning
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Robust Radiotherapy Planning
Serious events: 5 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Margin-Based Radiotherapy Planning
n=10 participants at risk
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area.
Margin-Based Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area
|
Robust Radiotherapy Planning
n=13 participants at risk
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue.
Robust Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
1/10 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
0.00%
0/13 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
0.00%
0/13 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
1/10 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
0.00%
0/13 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Investigations
Lymphocyte count decreased
|
10.0%
1/10 • Number of events 3 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
30.8%
4/13 • Number of events 6 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Investigations
Neutrophil count decreased
|
10.0%
1/10 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
10.0%
1/10 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
0.00%
0/13 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Infections and infestations
Sepsis
|
20.0%
2/10 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
0.00%
0/13 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Infections and infestations
Skin infection
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Investigations
White blood cell decreased
|
10.0%
1/10 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
1/10 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
0.00%
0/13 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
General disorders
Death NOS
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
Other adverse events
| Measure |
Margin-Based Radiotherapy Planning
n=10 participants at risk
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area.
Margin-Based Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area
|
Robust Radiotherapy Planning
n=13 participants at risk
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue.
Robust Radiotherapy planning: Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
1/10 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
38.5%
5/13 • Number of events 7 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
2/10 • Number of events 8 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
38.5%
5/13 • Number of events 8 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
2/10 • Number of events 3 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
23.1%
3/13 • Number of events 3 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
0.00%
0/13 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
30.8%
4/13 • Number of events 6 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Investigations
Creatinine increased
|
10.0%
1/10 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
15.4%
2/13 • Number of events 5 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
15.4%
2/13 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
0.00%
0/13 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
15.4%
2/13 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
2/10 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
38.5%
5/13 • Number of events 11 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
38.5%
5/13 • Number of events 9 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Gastrointestinal disorders
Dysphagia
|
20.0%
2/10 • Number of events 5 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
30.8%
4/13 • Number of events 13 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
15.4%
2/13 • Number of events 3 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Ear and labyrinth disorders
Ear pain
|
10.0%
1/10 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Gastrointestinal disorders
Esophagitis
|
10.0%
1/10 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
0.00%
0/13 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
General disorders
Fatigue
|
20.0%
2/10 • Number of events 3 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
46.2%
6/13 • Number of events 8 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
20.0%
2/10 • Number of events 3 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
23.1%
3/13 • Number of events 5 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
10.0%
1/10 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
0.00%
0/13 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
2/10 • Number of events 13 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
23.1%
3/13 • Number of events 7 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
1/10 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
0.00%
0/13 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
15.4%
2/13 • Number of events 3 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
15.4%
2/13 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
2/10 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
23.1%
3/13 • Number of events 4 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
2/10 • Number of events 7 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
23.1%
3/13 • Number of events 3 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
1/10 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
23.1%
3/13 • Number of events 4 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
1/10 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
2/10 • Number of events 3 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
30.8%
4/13 • Number of events 10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
15.4%
2/13 • Number of events 3 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
General disorders
Injection site reaction
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Investigations
INR increased
|
10.0%
1/10 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
0.00%
0/13 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Psychiatric disorders
Insomnia
|
20.0%
2/10 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
15.4%
2/13 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Investigations
Investigations - Other, specify
|
20.0%
2/10 • Number of events 11 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
15.4%
2/13 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Investigations
Lymphocyte count decreased
|
20.0%
2/10 • Number of events 6 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
46.2%
6/13 • Number of events 18 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
15.4%
2/13 • Number of events 4 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
23.1%
3/13 • Number of events 4 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
23.1%
3/13 • Number of events 3 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
23.1%
3/13 • Number of events 4 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
15.4%
2/13 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
10.0%
1/10 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
0.00%
0/13 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Investigations
Platelet count decreased
|
20.0%
2/10 • Number of events 9 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
30.8%
4/13 • Number of events 5 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
10.0%
1/10 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
0.00%
0/13 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
15.4%
2/13 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Infections and infestations
Skin infection
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
15.4%
2/13 • Number of events 3 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
15.4%
2/13 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.0%
1/10 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
23.1%
3/13 • Number of events 6 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
10.0%
1/10 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
23.1%
3/13 • Number of events 5 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Investigations
Weight loss
|
20.0%
2/10 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
15.4%
2/13 • Number of events 4 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Investigations
White blood cell decreased
|
10.0%
1/10 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
38.5%
5/13 • Number of events 17 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
General disorders
Edema limbs
|
10.0%
1/10 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
0.00%
0/13 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
General disorders
Neck edema
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Investigations
GGT increased
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
15.4%
2/13 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
10.0%
1/10 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
38.5%
5/13 • Number of events 6 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Eye disorders
Scleral disorder
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
10.0%
1/10 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
0.00%
0/13 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
15.4%
2/13 • Number of events 2 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/10 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
7.7%
1/13 • Number of events 1 • Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
|
Additional Information
Rashad Perry
University of Arkansas for Medical Sciences
Phone: 501-686-8274
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place