Trial Outcomes & Findings for Dose-Escalated Hypofractionated Adaptive Radiotherapy for Head and Neck Cancer (NCT NCT04477759)
NCT ID: NCT04477759
Last Updated: 2025-07-15
Results Overview
This measure is the number of subjects experiencing a dose-limiting toxicity. A dose-limiting toxicity is defined as an inability to complete radiation treatment within 30 days of the start of radiotherapy that is not deemed to be related to disease progression; OR an unacceptable toxicity within one year of treatment (Grade 4+ toxicity) that is probably or definitely related to radiation treatment as determined by the treating physician or a death within one year of treatment that is probably or definitely related to treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
12 months
Results posted on
2025-07-15
Participant Flow
Participant milestones
| Measure |
50 Gray (Gy) Radiation Therapy With Concurrent Atezolizumab
50 Gy of ionizing radiation therapy will be administered in 15 fractions. 50 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 4 weeks following the initiation of radiation treatment up to 1 year from radiation fraction 1.
|
50 Gray (Gy) Radiation Therapy With Adjuvant Atezolizumab
50 Gy of ionizing radiation therapy will be administered in 15 fractions. 50 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
55 Gray (Gy) Radiation Therapy With Adjuvant Atezolizumab
55 Gy of ionizing radiation therapy will be administered in 15 fractions. 55 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
60 Gray (Gy) Radiation Therapy With Adjuvant Atezolizumab
60 Gy of ionizing radiation therapy will be administered in 15 fractions. 60 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
3
|
7
|
|
Overall Study
COMPLETED
|
5
|
3
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose-Escalated Hypofractionated Adaptive Radiotherapy for Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
50 Gray (Gy) Radiation Therapy With Concurrent Atezolizumab
n=5 Participants
50 Gy of ionizing radiation therapy will be administered in 15 fractions. 50 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 4 weeks following the initiation of radiation treatment up to 1 year from radiation fraction 1.
|
50 Gray (Gy) Radiation Therapy
n=3 Participants
50 Gy of ionizing radiation therapy will be administered in 15 fractions.
50 Gy Radiation Therapy: Ionizing radiation
Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 4 weeks following the initiation of radiation treatment up to 1 year from radiation fraction 1.
|
55 Gray (Gy) Radiation Therapy
n=3 Participants
55 Gy of ionizing radiation therapy will be administered in 15 fractions.
55 Gy Radiation Therapy: Ionizing radiation
Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 4 weeks following the initiation of radiation treatment up to 1 year from radiation fraction 1.
|
60 Gray (Gy) Radiation Therapy
n=7 Participants
60 Gy of ionizing radiation therapy will be administered in 15 fractions.
60 Gy Radiation Therapy: Ionizing radiation
Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 4 weeks following the initiation of radiation treatment up to 1 year from radiation fraction 1.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
7 participants
n=4 Participants
|
18 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: This applies only to this primary outcome measure.
This measure is the number of subjects experiencing a dose-limiting toxicity. A dose-limiting toxicity is defined as an inability to complete radiation treatment within 30 days of the start of radiotherapy that is not deemed to be related to disease progression; OR an unacceptable toxicity within one year of treatment (Grade 4+ toxicity) that is probably or definitely related to radiation treatment as determined by the treating physician or a death within one year of treatment that is probably or definitely related to treatment.
Outcome measures
| Measure |
50 Gray (Gy) Radiation Therapy With Concurrent Atezolizumab
n=5 Participants
50 Gy of ionizing radiation therapy will be administered in 15 fractions. 50 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 4 weeks following the initiation of radiation treatment up to 1 year from radiation fraction 1.
|
50 Gray (Gy) Radiation Therapy
50 Gy of ionizing radiation therapy will be administered in 15 fractions. 50 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
55 Gray (Gy) Radiation Therapy
55 Gy of ionizing radiation therapy will be administered in 15 fractions. 55 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
60 Gray (Gy) Radiation Therapy
60 Gy of ionizing radiation therapy will be administered in 15 fractions. 60 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
|---|---|---|---|---|
|
Incidence of Dose-Limiting Toxicities at 50 Gy With Concurrent Atezolizumab
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: This applies only to this primary outcome.
This measure is the number of subjects experiencing a dose-limiting toxicity. A dose-limiting toxicity is defined as an inability to complete radiation treatment within 30 days of the start of radiotherapy that is not deemed to be related to disease progression; OR an unacceptable toxicity within one year of treatment (Grade 4+ toxicity) that is probably or definitely related to radiation treatment as determined by the treating physician or a death within one year of treatment that is probably or definitely related to treatment.
Outcome measures
| Measure |
50 Gray (Gy) Radiation Therapy With Concurrent Atezolizumab
50 Gy of ionizing radiation therapy will be administered in 15 fractions. 50 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 4 weeks following the initiation of radiation treatment up to 1 year from radiation fraction 1.
|
50 Gray (Gy) Radiation Therapy
n=3 Participants
50 Gy of ionizing radiation therapy will be administered in 15 fractions. 50 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
55 Gray (Gy) Radiation Therapy
55 Gy of ionizing radiation therapy will be administered in 15 fractions. 55 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
60 Gray (Gy) Radiation Therapy
60 Gy of ionizing radiation therapy will be administered in 15 fractions. 60 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
|---|---|---|---|---|
|
Incidence of Dose-Limiting Toxicities at 50 Gy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: This applies only to this primary outcome measure.
This measure is the number of subjects experiencing a dose-limiting toxicity. A dose-limiting toxicity is defined as an inability to complete radiation treatment within 30 days of the start of radiotherapy that is not deemed to be related to disease progression; OR an unacceptable toxicity within one year of treatment (Grade 4+ toxicity) that is probably or definitely related to radiation treatment as determined by the treating physician or a death within one year of treatment that is probably or definitely related to treatment.
Outcome measures
| Measure |
50 Gray (Gy) Radiation Therapy With Concurrent Atezolizumab
50 Gy of ionizing radiation therapy will be administered in 15 fractions. 50 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 4 weeks following the initiation of radiation treatment up to 1 year from radiation fraction 1.
|
50 Gray (Gy) Radiation Therapy
50 Gy of ionizing radiation therapy will be administered in 15 fractions. 50 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
55 Gray (Gy) Radiation Therapy
n=3 Participants
55 Gy of ionizing radiation therapy will be administered in 15 fractions. 55 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
60 Gray (Gy) Radiation Therapy
60 Gy of ionizing radiation therapy will be administered in 15 fractions. 60 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
|---|---|---|---|---|
|
Incidence of Dose-Limiting Toxicities at 55 Gy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: This applies to this outcome measure.
This measure is the number of subjects experiencing a dose-limiting toxicity. A dose-limiting toxicity is defined as an inability to complete radiation treatment within 30 days of the start of radiotherapy that is not deemed to be related to disease progression; OR an unacceptable toxicity within one year of treatment (Grade 4+ toxicity) that is probably or definitely related to radiation treatment as determined by the treating physician or a death within one year of treatment that is probably or definitely related to treatment.
Outcome measures
| Measure |
50 Gray (Gy) Radiation Therapy With Concurrent Atezolizumab
50 Gy of ionizing radiation therapy will be administered in 15 fractions. 50 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 4 weeks following the initiation of radiation treatment up to 1 year from radiation fraction 1.
|
50 Gray (Gy) Radiation Therapy
50 Gy of ionizing radiation therapy will be administered in 15 fractions. 50 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
55 Gray (Gy) Radiation Therapy
55 Gy of ionizing radiation therapy will be administered in 15 fractions. 55 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
60 Gray (Gy) Radiation Therapy
n=7 Participants
60 Gy of ionizing radiation therapy will be administered in 15 fractions. 60 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
|---|---|---|---|---|
|
Incidence of Dose-Limiting Toxicities at 60 Gy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThis measure is the highest radiation dose at which there is a 30% or more rate of dose-limiting toxicity up to 12 months after completion of radiation treatment using the TITE-CRM design.
Outcome measures
| Measure |
50 Gray (Gy) Radiation Therapy With Concurrent Atezolizumab
n=18 Participants
50 Gy of ionizing radiation therapy will be administered in 15 fractions. 50 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 4 weeks following the initiation of radiation treatment up to 1 year from radiation fraction 1.
|
50 Gray (Gy) Radiation Therapy
50 Gy of ionizing radiation therapy will be administered in 15 fractions. 50 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
55 Gray (Gy) Radiation Therapy
55 Gy of ionizing radiation therapy will be administered in 15 fractions. 55 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
60 Gray (Gy) Radiation Therapy
60 Gy of ionizing radiation therapy will be administered in 15 fractions. 60 Gy Radiation Therapy: Ionizing radiation Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
|---|---|---|---|---|
|
Maximum Tolerated Radiation Dose
|
60 Gy
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearThis measure is the number of subjects alive at 1 year following the conclusion of scheduled radiation therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearThis measure is the number of subjects showing disease progression in the head and neck by RECIST criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6th Radiation Fraction (approximately 1 week)This measure is the change in gross tumor volume for each subject as contoured on pre-treatment (baseline) and treatment 6 imaging scans. This will be measured in cubic centimeters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 11th Radiation Fraction (approximately 2 weeks)This measure is the change in gross tumor volume for each subject as contoured on pre-treatment (baseline) and treatment 11 imaging scans. This will be measured in cubic centimeters.
Outcome measures
Outcome data not reported
Adverse Events
50 Gray (Gy) Radiation Therapy With Concurrent Atezolizumab
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
50 Gray (Gy) Radiation Therapy
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
55 Gray (Gy) Radiation Therapy
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
60 Gray (Gy) Radiation Therapy
Serious events: 6 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
50 Gray (Gy) Radiation Therapy With Concurrent Atezolizumab
n=5 participants at risk
50 Gy of ionizing radiation therapy will be administered in 15 fractions.
50 Gy Radiation Therapy: Ionizing radiation
Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 4 weeks following the initiation of radiation treatment up to 1 year from radiation fraction 1.
|
50 Gray (Gy) Radiation Therapy
n=3 participants at risk
50 Gy of ionizing radiation therapy will be administered in 15 fractions.
50 Gy Radiation Therapy: Ionizing radiation
Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
55 Gray (Gy) Radiation Therapy
n=3 participants at risk
55 Gy of ionizing radiation therapy will be administered in 15 fractions.
55 Gy Radiation Therapy: Ionizing radiation
Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
60 Gray (Gy) Radiation Therapy
n=7 participants at risk
60 Gy of ionizing radiation therapy will be administered in 15 fractions.
60 Gy Radiation Therapy: Ionizing radiation
Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Dysphagia
|
40.0%
2/5 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
42.9%
3/7 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Hypercalcemia
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
28.6%
2/7 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hyponatremia
|
40.0%
2/5 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
General disorders
fatigue
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
28.6%
2/7 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Investigations
weight loss
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
42.9%
3/7 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
42.9%
3/7 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Oral pain
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Infections and infestations
Pharyngitis
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Mucositis oral
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
General disorders
Chills
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
General disorders
Edema face
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Infections and infestations
Thrush
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Cardiac disorders
sinus tachycardia
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Infections and infestations
Lung infection - Pneumonia
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Confusion
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Vascular disorders
arterial thromboembolism
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
G-tube malfunction
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Infections and infestations
Herpes simplex reactivation
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
Lethargy
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
40.0%
2/5 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Renal and urinary disorders
acute kidney injury
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
nausea
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
General disorders
edema limbs
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
dysarthria
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Cardiac disorders
heart failure
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
esophagitis
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
paresthesia
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
Other adverse events
| Measure |
50 Gray (Gy) Radiation Therapy With Concurrent Atezolizumab
n=5 participants at risk
50 Gy of ionizing radiation therapy will be administered in 15 fractions.
50 Gy Radiation Therapy: Ionizing radiation
Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 4 weeks following the initiation of radiation treatment up to 1 year from radiation fraction 1.
|
50 Gray (Gy) Radiation Therapy
n=3 participants at risk
50 Gy of ionizing radiation therapy will be administered in 15 fractions.
50 Gy Radiation Therapy: Ionizing radiation
Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
55 Gray (Gy) Radiation Therapy
n=3 participants at risk
55 Gy of ionizing radiation therapy will be administered in 15 fractions.
55 Gy Radiation Therapy: Ionizing radiation
Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
60 Gray (Gy) Radiation Therapy
n=7 participants at risk
60 Gy of ionizing radiation therapy will be administered in 15 fractions.
60 Gy Radiation Therapy: Ionizing radiation
Atezolizumab: Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 28 days following the initiation of radiation treatment up to 1 year.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
28.6%
2/7 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Renal and urinary disorders
Acute kidney injury
|
40.0%
2/5 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Agitation
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
100.0%
3/3 • Number of events 13 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
100.0%
7/7 • Number of events 15 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
2/5 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
100.0%
7/7 • Number of events 9 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Anxiety
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Cardiac disorders
Atrial fibrillation
|
40.0%
2/5 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Cardiac disorders
Atrial flutter
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
General disorders
Chills
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Confusion
|
80.0%
4/5 • Number of events 4 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Constipation
|
60.0%
3/5 • Number of events 4 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
100.0%
3/3 • Number of events 4 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
71.4%
5/7 • Number of events 5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
2/5 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
42.9%
3/7 • Number of events 5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Dehydration
|
80.0%
4/5 • Number of events 5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
71.4%
5/7 • Number of events 8 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Delusions
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
42.9%
3/7 • Number of events 4 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
5/5 • Number of events 6 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
42.9%
3/7 • Number of events 4 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
Dizziness
|
40.0%
2/5 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
42.9%
3/7 • Number of events 5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Dry mouth
|
80.0%
4/5 • Number of events 4 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
100.0%
3/3 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
71.4%
5/7 • Number of events 7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
Dysarthria
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
28.6%
2/7 • Number of events 4 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
Dysgeusia
|
60.0%
3/5 • Number of events 4 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
100.0%
3/3 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 4 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
57.1%
4/7 • Number of events 7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Dysphagia
|
100.0%
5/5 • Number of events 11 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
100.0%
3/3 • Number of events 6 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
100.0%
7/7 • Number of events 16 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.0%
2/5 • Number of events 5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
General disorders
edema face
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
57.1%
4/7 • Number of events 4 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
General disorders
Edema limbs
|
40.0%
2/5 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
Encephalopathy
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
General disorders
Fatigue
|
80.0%
4/5 • Number of events 6 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 4 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
100.0%
3/3 • Number of events 4 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
100.0%
7/7 • Number of events 10 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
General disorders
Fever
|
60.0%
3/5 • Number of events 5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Vascular disorders
Flushing
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Thick secretions
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Secretions
|
40.0%
2/5 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
G-tube displacement
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
40.0%
2/5 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Cardiac disorders
Heart failure
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Infections and infestations
Herpes simplex reactivation
|
60.0%
3/5 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
28.6%
2/7 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
42.9%
3/7 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 6 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
57.1%
4/7 • Number of events 9 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
40.0%
2/5 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
28.6%
2/7 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hyponatremia
|
60.0%
3/5 • Number of events 9 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 4 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
42.9%
3/7 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
28.6%
2/7 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
40.0%
2/5 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
42.9%
3/7 • Number of events 5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
28.6%
2/7 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal obstruction
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
lethargy
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Lipase increased
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
100.0%
3/3 • Number of events 5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
General disorders
localized edema
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Vascular disorders
Lymphedema
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
42.9%
3/7 • Number of events 4 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Mucositis oral
|
100.0%
5/5 • Number of events 9 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
100.0%
3/3 • Number of events 8 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
100.0%
3/3 • Number of events 5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
85.7%
6/7 • Number of events 15 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
42.9%
3/7 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
20.0%
1/5 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Oral pain
|
80.0%
4/5 • Number of events 8 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
71.4%
5/7 • Number of events 9 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
40.0%
2/5 • Number of events 4 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
General disorders
Pain
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
28.6%
2/7 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal necrosis
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Infections and infestations
Pharyngitis
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
28.6%
2/7 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
40.0%
2/5 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Neck ococutaneous fistula
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Serum amylase increased
|
40.0%
2/5 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Infections and infestations
Shingles
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
40.0%
2/5 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
71.4%
5/7 • Number of events 7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Infections and infestations
Thrush
|
20.0%
1/5 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
71.4%
5/7 • Number of events 7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Thyroid stimulating hormone increased
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
60.0%
3/5 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
100.0%
3/3 • Number of events 4 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
40.0%
2/5 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
28.6%
2/7 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Weight loss
|
60.0%
3/5 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
100.0%
3/3 • Number of events 7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
85.7%
6/7 • Number of events 16 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Vascular disorders
Arterial thromboembolism
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Creatinine increased
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Ear and labyrinth disorders
cerumen impaction
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Ear and labyrinth disorders
ear pain
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
28.6%
2/7 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Injury, poisoning and procedural complications
fall
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Blood tinged secretions
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
mouth swelling
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
mouth sore
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
G tube malfunction
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
General disorders
jaw pain
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
headache
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
42.9%
3/7 • Number of events 6 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
42.9%
3/7 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Injury, poisoning and procedural complications
Injury to carotid artery
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
66.7%
2/3 • Number of events 10 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
85.7%
6/7 • Number of events 17 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
General disorders
Neck edema
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
28.6%
2/7 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transverse colon polyp
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
28.6%
2/7 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Skin and subcutaneous tissue disorders
Open area anterior Right foot
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Injury, poisoning and procedural complications
Tracheostomy site bleeding
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
33.3%
1/3 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Cholecystitis
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
28.6%
2/7 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
28.6%
2/7 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Ear and labyrinth disorders
Left ear pain/pressure/popping
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
General disorders
Facial pain
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Eye disorders
Floaters
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Mucus/phlegm
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Hepatobiliary disorders
cholelithiasis
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Vascular disorders
Hot flashes
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Infections and infestations
Lung infection
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
28.6%
2/7 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
General disorders
Malaise
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
cyst on left side of neck
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
28.6%
2/7 • Number of events 3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
28.6%
2/7 • Number of events 2 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
Tremor
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Injury, poisoning and procedural complications
DVT in PICC line
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Eye disorders
Watering eyes
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/5 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
14.3%
1/7 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Gingival pain
|
20.0%
1/5 • Number of events 1 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/3 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
0.00%
0/7 • 1 year following the end of radiation (up to 1 year and 3 weeks)
regular investigator assessment, regular laboratory testing
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place