Trial Outcomes & Findings for Pembrolizumab After Radiation Therapy in Treating Patients With Pleural Malignant Mesothelioma (NCT NCT02959463)
NCT ID: NCT02959463
Last Updated: 2025-11-13
Results Overview
To determine the safety and tolerability of pembrolizumab administered after radiation therapy in patients with MPM. The primary endpoint was "unaccepable" high grade adverse events (AEs) from baseline to 4-month after the start of radiation therapy.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Baseline to 4-months after the start of radiation therapy
Results posted on
2025-11-13
Participant Flow
Single center trial that recruited patients at one hospital site (MD Anderson Cancer Center, Houston, TX)
Participant milestones
| Measure |
Cohort 1
Patient with lung intact to receive hemithoracic radiation therapy for definitive intent
|
Cohort 2
Patients with lung intact to receive non-hemithoracic radiation therapy(palliative radiation therapy)
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1
Patient with lung intact to receive hemithoracic radiation therapy for definitive intent
|
Cohort 2
Patients with lung intact to receive non-hemithoracic radiation therapy(palliative radiation therapy)
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Pembrolizumab After Radiation Therapy in Treating Patients With Pleural Malignant Mesothelioma
Baseline characteristics by cohort
| Measure |
Cohort 1
n=12 Participants
Patient with lung intact to receive hemithoracic radiation therapy for definitive intent
|
Cohort 2
n=12 Participants
Patients with lung intact to receive non-hemithoracic radiation therapy(palliative radiation therapy)
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
8 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
16 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
8 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=10 Participants
|
7 Participants
n=10 Participants
|
16 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
22 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
21 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=10 Participants
|
12 participants
n=10 Participants
|
24 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Baseline to 4-months after the start of radiation therapyTo determine the safety and tolerability of pembrolizumab administered after radiation therapy in patients with MPM. The primary endpoint was "unaccepable" high grade adverse events (AEs) from baseline to 4-month after the start of radiation therapy.
Outcome measures
| Measure |
Cohort 2
n=12 Participants
Patients with lung intact to receive non-hemithoracic radiation therapy(palliative radiation therapy)
|
Cohort 1
n=12 Participants
Patient with lung intact to receive hemithoracic radiation therapy for definitive intent
|
|---|---|---|
|
Safety/Toxicity
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Every 6 weeks (42 +/- 7 days) until to 48 weeks, then every 12 weeks (+/- 7 days) to 5 yearsTo assess overall survival (OS) in patients receiving Pembrolizumab after radiation therapy for MPM.
Outcome measures
| Measure |
Cohort 2
n=12 Participants
Patients with lung intact to receive non-hemithoracic radiation therapy(palliative radiation therapy)
|
Cohort 1
n=12 Participants
Patient with lung intact to receive hemithoracic radiation therapy for definitive intent
|
|---|---|---|
|
Overall Survival (OS)
|
16.3 months
Interval 6.3 to 22.2
|
12.2 months
Interval 7.7 to 23.6
|
SECONDARY outcome
Timeframe: Every 6 weeks (42 +/- 7 days) until to 48 weeks, then every 12 weeks (+/- 7 days) to 5 yearsTo assess progression-free survial (PFS) in patients receiving Pembrolizumab after radiation therapy for MPM.
Outcome measures
| Measure |
Cohort 2
n=12 Participants
Patients with lung intact to receive non-hemithoracic radiation therapy(palliative radiation therapy)
|
Cohort 1
n=12 Participants
Patient with lung intact to receive hemithoracic radiation therapy for definitive intent
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
4 months
Interval 3.3 to 11.4
|
7.7 months
Interval 4.2 to 19.8
|
Adverse Events
Cohort 1
Serious events: 6 serious events
Other events: 12 other events
Deaths: 11 deaths
Cohort 2
Serious events: 3 serious events
Other events: 12 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Cohort 1
n=12 participants at risk
Patient with lung intact to receive hemithoracic radiation therapy for definitive intent
|
Cohort 2
n=12 participants at risk
Patients with lung intact to receive non-hemithoracic radiation therapy(palliative radiation therapy)
|
|---|---|---|
|
General disorders
Death NOS
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
General disorders
Dysphagia
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
General disorders
Pain
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
General disorders
Esophagitis
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
General disorders
Gastritis
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Infections and infestations
Lung infection
|
41.7%
5/12 • Number of events 5 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Infections and infestations
Infections and infestations - Other
|
8.3%
1/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Investigations
Creatinine increased
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Metabolism and nutrition disorders
Anorexia
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Renal and urinary disorders
Acute Kidney injury
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
16.7%
2/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
16.7%
2/12 • Number of events 3 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal mucositis
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
Other adverse events
| Measure |
Cohort 1
n=12 participants at risk
Patient with lung intact to receive hemithoracic radiation therapy for definitive intent
|
Cohort 2
n=12 participants at risk
Patients with lung intact to receive non-hemithoracic radiation therapy(palliative radiation therapy)
|
|---|---|---|
|
Ear and labyrinth disorders
Ear Pain
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
6/12 • Number of events 12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
66.7%
8/12 • Number of events 8 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders-Other, specify
|
25.0%
3/12 • Number of events 8 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
41.7%
5/12 • Number of events 8 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Blood and lymphatic system disorders
Edema Limbs
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Cardiac disorders
Atrial fibrillation
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Cardiac disorders
Heart failure
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Cardiac disorders
Palpitations
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Cardiac disorders
Sinus tachycardia
|
8.3%
1/12 • Number of events 3 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Endocrine disorders
Endocrine disorders-Other,
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Endocrine disorders
Hypothyroidism
|
8.3%
1/12 • Number of events 5 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
16.7%
2/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Eye disorders
Blurred vision
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Gastrointestinal disorders
Alanine aminotransferase increased
|
16.7%
2/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Gastrointestinal disorders
Aspartate aminotransferase increased
|
25.0%
3/12 • Number of events 3 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Gastrointestinal disorders
Constipation
|
33.3%
4/12 • Number of events 5 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
25.0%
3/12 • Number of events 3 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Gastrointestinal disorders
Dysphagia
|
66.7%
8/12 • Number of events 11 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
41.7%
5/12 • Number of events 6 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Gastrointestinal disorders
Esophagitis
|
50.0%
6/12 • Number of events 7 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
33.3%
4/12 • Number of events 5 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Gastrointestinal disorders
Nausea
|
33.3%
4/12 • Number of events 8 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
33.3%
4/12 • Number of events 5 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
4/12 • Number of events 9 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
General disorders
Chills
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
General disorders
Edema Limbs
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
General disorders
Fatigue
|
91.7%
11/12 • Number of events 25 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
75.0%
9/12 • Number of events 16 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
General disorders
Fever
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
General disorders
Gait disturbance
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
General disorders
Non-cardiac chest pain
|
16.7%
2/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
16.7%
2/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
General disorders
Localized edema
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
General disorders
Pain
|
66.7%
8/12 • Number of events 17 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
33.3%
4/12 • Number of events 5 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Infections and infestations
Papulopustular rash
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Infections and infestations
Infections and infestations-Other,specify
|
8.3%
1/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
16.7%
2/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Investigations
Activated partial thromboplastin time prolonged
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
2/12 • Number of events 4 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
16.7%
2/12 • Number of events 3 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Investigations
Alanine aminotansferase increased
|
16.7%
2/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Investigations
Aspartate aminotansferase increased
|
25.0%
3/12 • Number of events 3 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Investigations
Creatinine increased
|
33.3%
4/12 • Number of events 5 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
33.3%
4/12 • Number of events 4 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Investigations
Lymphocyte count decreased
|
25.0%
3/12 • Number of events 14 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Investigations
Weight loss
|
16.7%
2/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
33.3%
4/12 • Number of events 4 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Investigations
White blood cell decreased
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
6/12 • Number of events 9 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
25.0%
3/12 • Number of events 3 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
3/12 • Number of events 3 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
16.7%
2/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.3%
1/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
2/12 • Number of events 3 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
2/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
16.7%
2/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.7%
2/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Nervous system disorders
Cognitive disturbance
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
16.7%
2/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Nervous system disorders
Nervous system disorders-Other, specify
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
2/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Nervous system disorders
Paresthesia
|
16.7%
2/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Nervous system disorders
Presyncope
|
16.7%
2/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Nervous system disorders
Stroke
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Psychiatric disorders
Anxiety
|
25.0%
3/12 • Number of events 3 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Psychiatric disorders
Depression
|
25.0%
3/12 • Number of events 3 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Psychiatric disorders
Insomnia
|
16.7%
2/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Renal and urinary disorders
Acute Kidney injury
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
83.3%
10/12 • Number of events 15 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
91.7%
11/12 • Number of events 12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
83.3%
10/12 • Number of events 16 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
66.7%
8/12 • Number of events 11 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
25.0%
3/12 • Number of events 3 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
16.7%
2/12 • Number of events 3 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Reproductive system and breast disorders
Breast Pain
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
25.0%
3/12 • Number of events 4 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders- Other,specify
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Social circumstances
Social circumstances-Other, specify
|
8.3%
1/12 • Number of events 2 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • Number of events 1 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
0.00%
0/12 • Baseline to 4-months after radiation therapy up to 5 years
Adverse events (AEs) and serious adverse events (SAEs) are monitered from the baseline to 4-months after Radiation therapy
|
Additional Information
Matthew Stephen Ning, MD, MPH
The University of Texas MD Anderson Cancer Center
Phone: (832) 710-8779
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place