Trial Outcomes & Findings for Pembrolizumab With Locally Delivered Radiation Therapy for the Treatment of Metastatic Esophageal Cancers (NCT NCT02642809)
NCT ID: NCT02642809
Last Updated: 2026-03-18
Results Overview
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 will be utilized for all toxicity reporting. In general, CTCAE version 4.03 has the following definitions for the grading scale: Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Through 30 days after completion of treatment (median length of adverse event follow-up 106 days, full range 42-1023 days)
Results posted on
2026-03-18
Participant Flow
Participant milestones
| Measure |
Pembrolizumab and Brachytherapy
* Brachytherapy dose=16 Gy delivered in 2 fractions of 8 Gy per fraction, separated by 7-10 days between fractions.
* Pembrolizumab started within 1 week after completion of brachytherapy administered as an intravenous infusion with a dose of 200 mg. It will be given every 3 weeks.
* Research endoscopic biopsy for 8 consented patients will take place 1-2 weeks after initiation of brachytherapy.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab With Locally Delivered Radiation Therapy for the Treatment of Metastatic Esophageal Cancers
Baseline characteristics by cohort
| Measure |
Pembrolizumab and Brachytherapy
n=16 Participants
* Brachytherapy dose=16 Gy delivered in 2 fractions of 8 Gy per fraction, separated by 7-10 days between fractions.
* Pembrolizumab started within 1 week after completion of brachytherapy administered as an intravenous infusion with a dose of 200 mg. It will be given every 3 weeks.
* Research endoscopic biopsy for 8 consented patients will take place 1-2 weeks after initiation of brachytherapy.
|
|---|---|
|
Age, Continuous
|
64 years
n=110 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=110 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=110 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=110 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=110 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=110 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=110 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=110 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=110 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=110 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=110 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=110 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=110 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=110 Participants
|
PRIMARY outcome
Timeframe: Through 30 days after completion of treatment (median length of adverse event follow-up 106 days, full range 42-1023 days)The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 will be utilized for all toxicity reporting. In general, CTCAE version 4.03 has the following definitions for the grading scale: Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
Outcome measures
| Measure |
Pembrolizumab and Brachytherapy
n=16 Participants
* Brachytherapy dose=16 Gy delivered in 2 fractions of 8 Gy per fraction, separated by 7-10 days between fractions.
* Pembrolizumab started within 1 week after completion of brachytherapy administered as an intravenous infusion with a dose of 200 mg. It will be given every 3 weeks.
* Research endoscopic biopsy for 8 consented patients will take place 1-2 weeks after initiation of brachytherapy.
|
|---|---|
|
Safety as Measured by Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Grade 4 AST elevation
|
1 Participants
|
|
Safety as Measured by Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Grade 3 dyspnea
|
1 Participants
|
|
Safety as Measured by Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Grade 3 vomiting
|
1 Participants
|
|
Safety as Measured by Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Grade 3 abdominal pain
|
1 Participants
|
|
Safety as Measured by Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Grade 3 nausea
|
1 Participants
|
|
Safety as Measured by Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Grade 3 headache
|
1 Participants
|
|
Safety as Measured by Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Grade 3 fatigue
|
1 Participants
|
|
Safety as Measured by Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Grade 3 failure to thrive
|
1 Participants
|
|
Safety as Measured by Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Grade 3 lymphocytopenia
|
1 Participants
|
|
Safety as Measured by Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Grade 3 ALT elevation
|
1 Participants
|
|
Safety as Measured by Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Grade 3 hyperbilirubinemia
|
1 Participants
|
SECONDARY outcome
Timeframe: Prior to brachytherapy and once anytime between 2-6 months after start of pembrolizumab (up to approximately 7 months post-baseline)Population: 4 patients were not evaluable for this outcome measure because there were difficulties assessing the distinct margins of their tumors given diffuse submucosal involvement.
Outcome measures
| Measure |
Pembrolizumab and Brachytherapy
n=12 Participants
* Brachytherapy dose=16 Gy delivered in 2 fractions of 8 Gy per fraction, separated by 7-10 days between fractions.
* Pembrolizumab started within 1 week after completion of brachytherapy administered as an intravenous infusion with a dose of 200 mg. It will be given every 3 weeks.
* Research endoscopic biopsy for 8 consented patients will take place 1-2 weeks after initiation of brachytherapy.
|
|---|---|
|
Mean Percent Change in Esophageal Tumor Length as Measured by Endoscopy
|
-4.0 percent change
Interval -22.0 to 10.0
|
SECONDARY outcome
Timeframe: Prior to brachytherapy, at 1-2 weeks after initiation of brachytherapy (optional), and 2-6 months after start of pembrolizumabPopulation: During study design it was hypothesized that the esophageal lumen size would be measurable in patients and such measurements would be reproducible. However, upon reviewing the actual endoscopy procedures it was discovered that luminal diameter was difficult to assess due to inter-patient and inter-procedure variability. No data could be collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment through 8 weeks post-pembrolizumab (median length of dysphagia follow-up 132 days, full range 42-1049 days)The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 will be utilized for all toxicity reporting. Grade 1: symptomatic, able to eat regular diet; Grade 2: symptomatic and altered eating/swallowing; Grade 3: severely altered eating/swallowing; tube feeding or TPN or hospitalization indicated; Grade 4: life-threatening consequences; urgent intervention indicated; Grade 5: death.
Outcome measures
| Measure |
Pembrolizumab and Brachytherapy
n=16 Participants
* Brachytherapy dose=16 Gy delivered in 2 fractions of 8 Gy per fraction, separated by 7-10 days between fractions.
* Pembrolizumab started within 1 week after completion of brachytherapy administered as an intravenous infusion with a dose of 200 mg. It will be given every 3 weeks.
* Research endoscopic biopsy for 8 consented patients will take place 1-2 weeks after initiation of brachytherapy.
|
|---|---|
|
Worst Grade of Dysphagia Experienced by Participant
No dysphagia
|
11 Participants
|
|
Worst Grade of Dysphagia Experienced by Participant
Grade 1
|
2 Participants
|
|
Worst Grade of Dysphagia Experienced by Participant
Grade 2
|
2 Participants
|
|
Worst Grade of Dysphagia Experienced by Participant
Grade 3
|
1 Participants
|
|
Worst Grade of Dysphagia Experienced by Participant
Grade 4
|
0 Participants
|
|
Worst Grade of Dysphagia Experienced by Participant
Grade 5
|
0 Participants
|
SECONDARY outcome
Timeframe: Through completion of treatment (median length of treatment 76 days, full range 25-993 days)Population: 5 patients were not evaluable for this outcome measure as they did not have a response assessment after the baseline assessment.
\- Response and progression will be evaluated in this study using Immune-Related Response Criteria. * irCR, complete disappearance of all lesions (whether measurable or not, and no new lesions) - confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented * irPR, decrease in tumor burden ≥ 50% relative to baseline - confirmed by a consecutive assessment at least 4 weeks after first documentation * irSD, not meeting criteria for irCR or irPR, in absence of irPD * irPD, increase in tumor burden ≥ 25% relative to nadir (minimum recorded tumor burden) - confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented * Patients are considered to have irPR or irSD even if new lesions are present as long as they meet the respective thresholds of response as described above. Furthermore, patients are not considered to have irPD if new lesions are present and the tumor burden of all lesions.
Outcome measures
| Measure |
Pembrolizumab and Brachytherapy
n=11 Participants
* Brachytherapy dose=16 Gy delivered in 2 fractions of 8 Gy per fraction, separated by 7-10 days between fractions.
* Pembrolizumab started within 1 week after completion of brachytherapy administered as an intravenous infusion with a dose of 200 mg. It will be given every 3 weeks.
* Research endoscopic biopsy for 8 consented patients will take place 1-2 weeks after initiation of brachytherapy.
|
|---|---|
|
Overall Response as Measured by Immune-Related Response Criteria (irRC)
irCR
|
0 Participants
|
|
Overall Response as Measured by Immune-Related Response Criteria (irRC)
irPR
|
2 Participants
|
|
Overall Response as Measured by Immune-Related Response Criteria (irRC)
irSD
|
2 Participants
|
|
Overall Response as Measured by Immune-Related Response Criteria (irRC)
irPD
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 1 year after completion of treatment (median length of treatment 76 days, full range 25-993 days)PFS was defined as the duration from the first infusion of pembrolizumab until disease progression or death (whichever occurred first).
Outcome measures
| Measure |
Pembrolizumab and Brachytherapy
n=16 Participants
* Brachytherapy dose=16 Gy delivered in 2 fractions of 8 Gy per fraction, separated by 7-10 days between fractions.
* Pembrolizumab started within 1 week after completion of brachytherapy administered as an intravenous infusion with a dose of 200 mg. It will be given every 3 weeks.
* Research endoscopic biopsy for 8 consented patients will take place 1-2 weeks after initiation of brachytherapy.
|
|---|---|
|
Median Progression-free Survival (PFS)
|
2.5 months
Interval 2.1 to 4.3
|
SECONDARY outcome
Timeframe: Up to 1 year after completion of treatment (median length of treatment 76 days, full range 25-993 days)OS was defined as the duration from the first infusion of pembrolizumab until death.
Outcome measures
| Measure |
Pembrolizumab and Brachytherapy
n=16 Participants
* Brachytherapy dose=16 Gy delivered in 2 fractions of 8 Gy per fraction, separated by 7-10 days between fractions.
* Pembrolizumab started within 1 week after completion of brachytherapy administered as an intravenous infusion with a dose of 200 mg. It will be given every 3 weeks.
* Research endoscopic biopsy for 8 consented patients will take place 1-2 weeks after initiation of brachytherapy.
|
|---|---|
|
Median Overall Survival (OS)
|
7.2 months
Interval 1.6 to 15.9
|
Adverse Events
Pembrolizumab and Brachytherapy
Serious events: 12 serious events
Other events: 16 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Pembrolizumab and Brachytherapy
n=16 participants at risk
* Brachytherapy dose=16 Gy delivered in 2 fractions of 8 Gy per fraction, separated by 7-10 days between fractions.
* Pembrolizumab started within 1 week after completion of brachytherapy administered as an intravenous infusion with a dose of 200 mg. It will be given every 3 weeks.
* Research endoscopic biopsy for 8 consented patients will take place 1-2 weeks after initiation of brachytherapy.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Cardiac disorders
Myocardial infarction
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
General disorders
Death due to disease progression
|
12.5%
2/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
General disorders
Failure to thrive
|
12.5%
2/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Nervous system disorders
Stroke
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Renal and urinary disorders
Acute kidney injury
|
12.5%
2/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Vascular disorders
Thromboembolic event
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
Other adverse events
| Measure |
Pembrolizumab and Brachytherapy
n=16 participants at risk
* Brachytherapy dose=16 Gy delivered in 2 fractions of 8 Gy per fraction, separated by 7-10 days between fractions.
* Pembrolizumab started within 1 week after completion of brachytherapy administered as an intravenous infusion with a dose of 200 mg. It will be given every 3 weeks.
* Research endoscopic biopsy for 8 consented patients will take place 1-2 weeks after initiation of brachytherapy.
|
|---|---|
|
Gastrointestinal disorders
Flatulence
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Gastrointestinal disorders
Mucositis oral
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Gastrointestinal disorders
Nausea
|
43.8%
7/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Gastrointestinal disorders
Stomach pain
|
25.0%
4/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Gastrointestinal disorders
Throat pain
|
12.5%
2/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Gastrointestinal disorders
Vomiting
|
31.2%
5/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
General disorders
Fatigue
|
50.0%
8/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
General disorders
Knot in stomach
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Gastrointestinal disorders
Excessive saliva
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
2/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Cardiac disorders
Sinus tachycardia
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
4/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Gastrointestinal disorders
Belching
|
12.5%
2/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Gastrointestinal disorders
Bloating
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Gastrointestinal disorders
Constipation
|
43.8%
7/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
4/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Gastrointestinal disorders
Dyspepsia
|
18.8%
3/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
4/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Gastrointestinal disorders
Esophagitis
|
12.5%
2/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
General disorders
Non-cardiac chest pain
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
General disorders
Port site pain
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Hepatobiliary disorders
Liver pain
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Injury, poisoning and procedural complications
Bruising
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
2/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Investigations
Alkaline phosphatase increased
|
12.5%
2/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
2/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Investigations
Blood bilirubin increased
|
12.5%
2/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Investigations
Creatinine increased
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Investigations
Lymphocyte count decreased
|
18.8%
3/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Investigations
Lymphocyte count increased
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Investigations
Platelet count decreased
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Investigations
Weight loss
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Metabolism and nutrition disorders
Anorexia
|
56.2%
9/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Metabolism and nutrition disorders
BUN increased
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
4/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Musculoskeletal and connective tissue disorders
Cancer pain
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Musculoskeletal and connective tissue disorders
Leg cramps
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Musculoskeletal and connective tissue disorders
Leg locking
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
12.5%
2/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.8%
3/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Musculoskeletal and connective tissue disorders
Pain
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Musculoskeletal and connective tissue disorders
Pain - right side
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Musculoskeletal and connective tissue disorders
Spasms
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Nervous system disorders
Dizziness
|
37.5%
6/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Nervous system disorders
Headache
|
18.8%
3/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.5%
2/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Psychiatric disorders
Anxiety
|
12.5%
2/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Psychiatric disorders
Insomnia
|
37.5%
6/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Renal and urinary disorders
Acute kidney injury
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
4/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
31.2%
5/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
2/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
12.5%
2/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
12.5%
2/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Skin and subcutaneous tissue disorders
Blisters
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
31.2%
5/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
25.0%
4/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Skin and subcutaneous tissue disorders
Sweating
|
25.0%
4/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Vascular disorders
Hot flashes
|
12.5%
2/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
|
Vascular disorders
Hypotension
|
18.8%
3/16 • - Adverse events, including serious adverse events, were collected from start of treatment through 30 days following the last day of treatment (median length of follow-up 106 days, full range 42-1023 days). - All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 298 days, full range 42-1383 days).
|
Additional Information
Dr. Cliff Robinson
Washington University School of Medicine
Phone: 314-362-8567
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place