Trial Outcomes & Findings for HYHOPE: De-intensified Hypofractionated Radiation Therapy for HPV-associated Oropharynx Cancer (NCT NCT04580446)
NCT ID: NCT04580446
Last Updated: 2025-12-15
Results Overview
The number of participants experiencing dose-limiting toxicities (DLTs) will be used to determine the maximally tolerated dose (MTD) or optimal fractionation of hypofractionated radiation therapy. Level 0: 46.5 Gy in 15 fractions Level -1: 52 Gy in 20 fractions
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
3 months
Results posted on
2025-12-15
Participant Flow
Participant milestones
| Measure |
Dose escalation phase: hypofractionated radiotherapy with cisplatin
Level 0: 46.5 Gy in 15 fractions, 5 fractions/week
Hypofractionated intensity modulated radiotherapy with concurrent chemotherapy (weekly cisplatin)
|
Dose expansion phase: hypofractionated radiotherapy with cisplatin
46.5 Gy in 15 fractions, 5 fractions/week
Hypofractionated intensity modulated radiotherapy with concurrent chemotherapy (weekly cisplatin)
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
18
|
|
Overall Study
COMPLETED
|
6
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HYHOPE: De-intensified Hypofractionated Radiation Therapy for HPV-associated Oropharynx Cancer
Baseline characteristics by cohort
| Measure |
Dose Escalation Phase: Hypofractionated Radiotherapy With Cisplatin
n=6 Participants
46.5 Gy in 15 fractions, 5 fractions/week, with (weekly cisplatin 40 mg/m2)
|
Dose Expansion Phase: Hypofractionated Radiotherapy With Cisplatin
n=18 Participants
46.5 Gy in 15 fractions, 5 fractions/week, with (weekly cisplatin 40 mg/m2)
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age (median range)
|
59.6 years
n=9 Participants
|
58.9 years
n=32 Participants
|
59.5 years
n=18 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
18 Participants
n=32 Participants
|
23 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · White
|
4 Participants
n=9 Participants
|
14 Participants
n=32 Participants
|
18 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Hispanic
|
1 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · African American
|
1 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Asian
|
0 Participants
n=9 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Other/unknown
|
0 Participants
n=9 Participants
|
3 Participants
n=32 Participants
|
3 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=9 Participants
|
18 Participants
n=32 Participants
|
24 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Patients were enrolled using a rolling 6 design at dose level 0 (46.5 Gy in 15 fractions). Enrollment was paused to assess dose-limiting toxicity (DLT; grade 4 toxicity or persistent grade 3 mucositis ≤ 3 months post-treatment). Dose level 0 was evaluated for DLT occurrence. Following this, an expansion cohort was opened, bringing total enrollment to 24 participants. No participants were enrolled at dose level -1 (52 Gy in 20 fractions).
The number of participants experiencing dose-limiting toxicities (DLTs) will be used to determine the maximally tolerated dose (MTD) or optimal fractionation of hypofractionated radiation therapy. Level 0: 46.5 Gy in 15 fractions Level -1: 52 Gy in 20 fractions
Outcome measures
| Measure |
Hypofractionated radiotherapy with concurrent chemotherapy
n=6 Participants
Level 0: 46.5 Gy in 15 fractions, 5 fractions/week
Hypofractionated intensity modulated radiotherapy with concurrent weekly cisplatin 40 mg/m2
|
|---|---|
|
Maximally Tolerated Dose/Fractionation of Hypofractionated Radiation Therapy
|
0 Participants
|
SECONDARY outcome
Timeframe: 0-3 monthsToxicities as measured by CTCAE v5.0
Outcome measures
| Measure |
Hypofractionated radiotherapy with concurrent chemotherapy
n=24 Participants
Level 0: 46.5 Gy in 15 fractions, 5 fractions/week
Hypofractionated intensity modulated radiotherapy with concurrent weekly cisplatin 40 mg/m2
|
|---|---|
|
Clinician-reported Acute Toxicities
Oral mucositis (grade 3)
|
5 Participants
|
|
Clinician-reported Acute Toxicities
Odynophagia/sore throat (grade 2)
|
18 Participants
|
|
Clinician-reported Acute Toxicities
Oral mucositis (grade 2)
|
15 Participants
|
|
Clinician-reported Acute Toxicities
Weight loss/anorexia (grade 2)
|
13 Participants
|
|
Clinician-reported Acute Toxicities
Dysphagia ( grade 2)
|
11 Participants
|
|
Clinician-reported Acute Toxicities
Dysgeusia (grade 2)
|
9 Participants
|
|
Clinician-reported Acute Toxicities
Xerostomia (grade 2)
|
7 Participants
|
|
Clinician-reported Acute Toxicities
Nausea/vomiting (grade 2)
|
2 Participants
|
|
Clinician-reported Acute Toxicities
Odynophagia/sore throat (grade 3)
|
1 Participants
|
|
Clinician-reported Acute Toxicities
Weight loss/anorexia (grade 3)
|
2 Participants
|
|
Clinician-reported Acute Toxicities
Dysphagia (grade 3)
|
2 Participants
|
|
Clinician-reported Acute Toxicities
Nausea/vomiting (grade 3)
|
1 Participants
|
SECONDARY outcome
Timeframe: 3-12 monthsAs measured by CTCAE v5.0
Outcome measures
| Measure |
Hypofractionated radiotherapy with concurrent chemotherapy
n=24 Participants
Level 0: 46.5 Gy in 15 fractions, 5 fractions/week
Hypofractionated intensity modulated radiotherapy with concurrent weekly cisplatin 40 mg/m2
|
|---|---|
|
Clinician-reported Late Toxicities
Dysphagia (grade 2)
|
1 Participants
|
|
Clinician-reported Late Toxicities
Weight loss/anorexia (grade 2)
|
1 Participants
|
|
Clinician-reported Late Toxicities
Xerostomia (grade 2)
|
1 Participants
|
|
Clinician-reported Late Toxicities
Grade 3 AE
|
0 Participants
|
|
Clinician-reported Late Toxicities
Grade 4 AE
|
0 Participants
|
|
Clinician-reported Late Toxicities
Grade 5 AE
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsLocoregional control defined as freedom from locoregional recurrence. Locoregional recurrence defined as biopsy-proven viable cancer originating from the primary tumor site (i.e. oropharynx) or a lymph node basin above the clavicles.
Outcome measures
| Measure |
Hypofractionated radiotherapy with concurrent chemotherapy
n=24 Participants
Level 0: 46.5 Gy in 15 fractions, 5 fractions/week
Hypofractionated intensity modulated radiotherapy with concurrent weekly cisplatin 40 mg/m2
|
|---|---|
|
Percentage of Participants With Locoregional Control
|
86.2 percentage of participants
Interval 68.0 to 96.8
|
SECONDARY outcome
Timeframe: 1-12 monthsProgression-free survival defined as time from start of treatment to time of progression or death.
Outcome measures
| Measure |
Hypofractionated radiotherapy with concurrent chemotherapy
n=24 Participants
Level 0: 46.5 Gy in 15 fractions, 5 fractions/week
Hypofractionated intensity modulated radiotherapy with concurrent weekly cisplatin 40 mg/m2
|
|---|---|
|
Percentage of Participants With Progression Free Survival
|
82 percentage of participants
Interval 59.0 to 93.0
|
SECONDARY outcome
Timeframe: 24 monthsOverall survival defined as time from start of treatment o time of death.
Outcome measures
| Measure |
Hypofractionated radiotherapy with concurrent chemotherapy
n=24 Participants
Level 0: 46.5 Gy in 15 fractions, 5 fractions/week
Hypofractionated intensity modulated radiotherapy with concurrent weekly cisplatin 40 mg/m2
|
|---|---|
|
Percentage of Participants With Overall Survival
|
95.8 percentage of participants
Interval 74.0 to 99.0
|
SECONDARY outcome
Timeframe: 1-12 monthsChange from baseline in swallowing-related quality of life, as measured by the MD Anderson Dysphagia Inventory (MDADI) total score, assessed at specified time points (baseline,1, 3, 6, and 12 months) during and after treatment. Higher scores indicate better function, 0-100. Analyses were descriptive, and a paired t test was used to compare questionnaire results over time with P \< .05 considered statistically significant. MDADI composite score difference of 10 was deemed clinically meaningful.
Outcome measures
| Measure |
Hypofractionated radiotherapy with concurrent chemotherapy
n=24 Participants
Level 0: 46.5 Gy in 15 fractions, 5 fractions/week
Hypofractionated intensity modulated radiotherapy with concurrent weekly cisplatin 40 mg/m2
|
|---|---|
|
Swallowing-related Patient-reported Quality of Life
Baseline
|
86.5 score on a scale
Standard Deviation 13.7
|
|
Swallowing-related Patient-reported Quality of Life
1 mo
|
77.9 score on a scale
Standard Deviation 11.6
|
|
Swallowing-related Patient-reported Quality of Life
3 mo
|
85.5 score on a scale
Standard Deviation 11.3
|
|
Swallowing-related Patient-reported Quality of Life
6 mo
|
87.8 score on a scale
Standard Deviation 12.3
|
|
Swallowing-related Patient-reported Quality of Life
12 mo
|
89.4 score on a scale
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: 1-12 monthsChange from baseline in head and neck patient-reported outcomes quality of life, as measured by the University of Washington Quality of Life questionnaire (UW-QOL), assessed at specified time points (baseline,1, 3, 6, and 12 months) during and after treatment. Higher scores on UW-QOL subscales indicate better quality of life, 0 being worst and 100 being the best outcome. A paired t test was used to compare questionnaire results over time with P \< .05 considered statistically significant. UW-QOL was divided into 2 subscales of physical and social-emotional function with change of 0.5 x standard deviation (SD) and 0.8 x SD considered moderate and large effect, respectively. Scale title: Patient-reported quality of life at baseline and after treatment (0-100) Physical UW-QOL minimum: 45.83 Physical UW-QOL maximum: 100 Social-Emotional UW-QOL minimum: 17.5 Social-Emotional UW-QOL maximum: 100
Outcome measures
| Measure |
Hypofractionated radiotherapy with concurrent chemotherapy
n=24 Participants
Level 0: 46.5 Gy in 15 fractions, 5 fractions/week
Hypofractionated intensity modulated radiotherapy with concurrent weekly cisplatin 40 mg/m2
|
|---|---|
|
Head and Neck Patient-reported Quality of Life
Physical Baseline
|
93.4 score on a scale
Standard Deviation 9.9
|
|
Head and Neck Patient-reported Quality of Life
Physical 1 mo
|
74.9 score on a scale
Standard Deviation 11.4
|
|
Head and Neck Patient-reported Quality of Life
Physical 3 mo
|
80.3 score on a scale
Standard Deviation 11.3
|
|
Head and Neck Patient-reported Quality of Life
Physical 6 mo
|
84.8 score on a scale
Standard Deviation 11.7
|
|
Head and Neck Patient-reported Quality of Life
Physical 12 mo
|
85.3 score on a scale
Standard Deviation 11.7
|
|
Head and Neck Patient-reported Quality of Life
Social-Emotional Baseline
|
89.4 score on a scale
Standard Deviation 16.5
|
|
Head and Neck Patient-reported Quality of Life
Social-Emotional 1 mo
|
79.9 score on a scale
Standard Deviation 10.3
|
|
Head and Neck Patient-reported Quality of Life
Social-Emotional 3 mo
|
87.6 score on a scale
Standard Deviation 10.0
|
|
Head and Neck Patient-reported Quality of Life
Social-Emotional 6 mo
|
90.0 score on a scale
Standard Deviation 13.8
|
|
Head and Neck Patient-reported Quality of Life
Social-Emotional 12 mo
|
92.1 score on a scale
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: 1-12 monthsEuroQol-5 dimensions (EQ-5D-5L): 1-5, higher scores mean worse quality of life. Index score: 0-1, higher scores mean better quality of life. Visual Analog scale: 0-100, higher scores mean better quality of life.
Outcome measures
| Measure |
Hypofractionated radiotherapy with concurrent chemotherapy
n=24 Participants
Level 0: 46.5 Gy in 15 fractions, 5 fractions/week
Hypofractionated intensity modulated radiotherapy with concurrent weekly cisplatin 40 mg/m2
|
|---|---|
|
General Patient-reported Quality of Life
Index score 6 mo
|
0.915 score on a scale
Standard Deviation 0.166
|
|
General Patient-reported Quality of Life
Index score 12 mo
|
0.933 score on a scale
Standard Deviation 0.103
|
|
General Patient-reported Quality of Life
Visual Analog Scale Enrollment
|
86.8 score on a scale
Standard Deviation 12.4
|
|
General Patient-reported Quality of Life
Visual Analog Scale 1 mo
|
79.1 score on a scale
Standard Deviation 11.5
|
|
General Patient-reported Quality of Life
Visual Analog Scale 3 mo
|
81.9 score on a scale
Standard Deviation 12.0
|
|
General Patient-reported Quality of Life
Visual Analog Scale 6 mo
|
86.1 score on a scale
Standard Deviation 9.8
|
|
General Patient-reported Quality of Life
Visual Analog Scale 12 mo
|
88.9 score on a scale
Standard Deviation 8.0
|
|
General Patient-reported Quality of Life
Index score Enrollment
|
0.916 score on a scale
Standard Deviation 0.163
|
|
General Patient-reported Quality of Life
Index score 1 mo
|
0.879 score on a scale
Standard Deviation 0.107
|
|
General Patient-reported Quality of Life
Index score 3 mo
|
0.909 score on a scale
Standard Deviation 0.120
|
SECONDARY outcome
Timeframe: 1-12 monthsDependence on tube feeds defined as any participant with daily use of ≥2 nutritional supplements per day via the feeding tube at the time of evaluation.
Outcome measures
| Measure |
Hypofractionated radiotherapy with concurrent chemotherapy
n=24 Participants
Level 0: 46.5 Gy in 15 fractions, 5 fractions/week
Hypofractionated intensity modulated radiotherapy with concurrent weekly cisplatin 40 mg/m2
|
|---|---|
|
Feeding Tube Dependence
Acute follow up period
|
2 participants
|
|
Feeding Tube Dependence
Late follow up period
|
1 participants
|
Adverse Events
Hypofractionated radiotherapy with concurrent chemotherapy
Serious events: 6 serious events
Other events: 24 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Hypofractionated radiotherapy with concurrent chemotherapy
n=24 participants at risk
46.5 Gy in 15 fractions, 5 fractions/week
Dose escalation and dose expansion cohorts combined. Both cohorts received 46.5 Gy in 15 fractions so the data are combined.
Hypofractionated intensity modulated radiotherapy with concurrent weekly cisplatin 40 mg/m2
|
|---|---|
|
Vascular disorders
Thromboembolic event bilateral pulmonary embolism
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
General disorders
Death NOS
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
General disorders
Fever
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Investigations
Lymphocyte count decreased
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
Other adverse events
| Measure |
Hypofractionated radiotherapy with concurrent chemotherapy
n=24 participants at risk
46.5 Gy in 15 fractions, 5 fractions/week
Dose escalation and dose expansion cohorts combined. Both cohorts received 46.5 Gy in 15 fractions so the data are combined.
Hypofractionated intensity modulated radiotherapy with concurrent weekly cisplatin 40 mg/m2
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Immune system disorders
Allergic reaction
|
16.7%
4/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Reproductive system and breast disorders
Allergic rhinitis
|
45.8%
11/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
8/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Nervous system disorders
Amnesia
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
4/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
70.8%
17/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Nervous system disorders
Anosmia
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Psychiatric disorders
Anxiety
|
29.2%
7/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
16.7%
4/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
4/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Cardiac disorders
Atrioventricular block first degree
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.8%
5/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, Lymphoma
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, Easy bruising/bleeding
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Eye disorders
Blurred vision
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Blood and lymphatic system disorders
Bood and lymphatic system disorders-Other, Enlarged lymph nodes
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Cardiac disorders
Cardiac disorders - Other, bradycardia
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Cardiac disorders
Cardiac disorders - Other, Coronary artery disease
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Eye disorders
Cataract
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Investigations
Cholesterol high
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, Frequent thirst
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Congenital, familial and genetic disorders
Congenital, familial and genetic disorders - Other, Pure hypercholesterolemia
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
16/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
62.5%
15/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Investigations
Creatinine increased
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Dental caries
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Psychiatric disorders
Depression
|
12.5%
3/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
100.0%
24/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
4/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Nervous system disorders
Dizziness
|
29.2%
7/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Eye disorders
Dry eye
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
100.0%
24/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Skin and subcutaneous tissue disorders
dry skin
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Nervous system disorders
Dysesthesia
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Nervous system disorders
Dysgeusia
|
100.0%
24/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
95.8%
23/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
3/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, Ear discharge
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, Hearing loss
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, Total cerumen impaction
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
37.5%
9/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
General disorders
Edema limbs
|
12.5%
3/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
General disorders
Edema Face
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Eye disorders
Eye disorders - Other, Discharge
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Eye disorders
Eye infection
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Eye disorders
Eye pain
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
General disorders
Facial pain
|
16.7%
4/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
General disorders
Fatigue
|
95.8%
23/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
General disorders
Fever
|
16.7%
4/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
General disorders
Flu like symptoms
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
33.3%
8/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, heart burn
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, sputum production
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, change in bowel movement
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Globus sensation
|
16.7%
4/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Thick secretions
|
29.2%
7/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Tongue swelling
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Dry throat
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Gastric pain
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, peri-rectal abscess
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Tongue pain
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Cold sores
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Increased secretions
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Odynophagia
|
100.0%
24/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Mucus production
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
General disorders
General disorders and administration site conditions - Other, Dislocated shoulder
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
General disorders
General disorders and administration site conditions - Other, Speech change
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
General disorders
General disorders and administration site conditions - Other, Cold intolerance
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
General disorders
General disorders and administration site conditions - Other, Heat intolerance
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Musculoskeletal and connective tissue disorders
Head soft tissue necrosis
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Nervous system disorders
Headache
|
12.5%
3/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Ear and labyrinth disorders
Hearing impaired
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
25.0%
6/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Vascular disorders
Hot flashes
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
3/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
4/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
33.3%
8/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Vascular disorders
Hypertension
|
79.2%
19/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Vascular disorders
Hypotension
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
4/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Infections and infestations
Infections and infestations - Other, COVID-19
|
25.0%
6/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Infections and infestations
Infections and infestations - Other, Hepatitis B infection
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, Appetite change
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, Type II Diabetes Mellitus
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
91.7%
22/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, Oropharyngeal erythema
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Periodontal disease
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
25.0%
6/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
4/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Rectal fissure
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, Nocturia
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Nervous system disorders
Spasticity
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, Extravasation injury
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Psychiatric disorders
Insomnia
|
25.0%
6/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Investigations
Investigations - Other, Hematocrit decreased
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Investigations
Investigations - Other, Red Blood Cell decreased
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Infections and infestations
Lung infection
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Vascular disorders
Lymphedema
|
33.3%
8/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
8/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
General disorders
Malaise
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Left neck mass
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Herniated disc
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Neck stiffness
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
3/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Cardiac disorders
Myocardial infarction
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
4/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Nausea
|
79.2%
19/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
General disorders
Neck edema
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
37.5%
9/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Renal cyst
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Breast cancer
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Polyps
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Nervous system disorders
Nervous system disorders - Other, Temperature sensitivity
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Nervous system disorders
Nervous system disorders - Other, Neuropathy
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Investigations
Neutrophil count decreased
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Oral Pain
|
37.5%
9/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
General disorders
Pain
|
20.8%
5/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
3/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Nervous system disorders
Paresthesia
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, Benign prostatic hyperplasia
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Hemoptysis
|
12.5%
3/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Asthma
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Bronchiectasis
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Orthopnea
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Snoring
|
16.7%
4/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Shortness of breath
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Eye disorders
Retinal detachment
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Infections and infestations
Sinusitis
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Pityriasis rosea
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Basal cell carcinoma
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Erythema
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Diaphoresis
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Hair sensitvity
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Itchiness
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
29.2%
7/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
95.8%
23/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, bilateral inguinal herniainguin
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, Fistulectomy anal
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, Root Canal
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, Feeding tube
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Endocrine disorders
Testosterone deficiency
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Vascular disorders
Thromboembolic event
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Infections and infestations
Thrush
|
29.2%
7/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Investigations
Thyroid stimulating hormone increased
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
41.7%
10/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Toothache
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Nervous system disorders
Transient ischemic attacks
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
20.8%
5/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Renal and urinary disorders
Urinary frequency
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Renal and urinary disorders
Urinary urgency
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Vascular disorders
Vascular disorders - Other, Aneurysm
|
8.3%
2/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Vascular disorders
Vascular disorders - Other, Aortic atherosclerosis
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
12.5%
3/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
4/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Investigations
Weight gain
|
4.2%
1/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Investigations
Weight loss
|
75.0%
18/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
12.5%
3/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
|
Investigations
White blood cell decreased
|
12.5%
3/24 • 1 year post radiation treatment.
All-Cause Mortality was assessed for 2 year post radiation treatment. Serious and Other Adverse Events were assessed for 1 year post radiation treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place