Trial Outcomes & Findings for Chemoradiation and Pembrolizumab Followed by Pembrolizumab and Lenvatinib Before Surgery for the Treatment of Non-metastatic Esophageal or Esophageal/Gastroesophageal Junction Cancer (NCT NCT04929392)
NCT ID: NCT04929392
Last Updated: 2026-06-23
Results Overview
Defined as no residual cancer cells, including lymph nodes under pathologic examination of the surgically resected specimen and/or a Tumor Regression Score of 0 by the College of American Pathologist (CAP) Cancer Protocol for Esophageal Carcinoma. Pathological CR rate will be estimated by the proportion of patients achieving pathological CR, along with the 95% exact binomial confidence interval.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
At 14 weeks after starting protocol chemoradiotherapy
Results posted on
2026-06-23
Participant Flow
Three patients were enrolled in the study. The study was closed to accrual due to slow/low accrual.
Participant milestones
| Measure |
Treatment (Chemoradiation, Pembrolizumab, Lenvatinib)
CHEMORADIATION PHASE: Patients receive carboplatin IV and paclitaxel IV QW for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo EBRT over 6 weeks and receive pembrolizumab IV over 30 minutes on day 1 of radiation therapy in the absence of disease progression or unacceptable toxicity.
WINDOW PERIOD: Patients receive pembrolizumab IV over 30 minutes on day 1 of week 3 and lenvatinib mesylate PO QD at weeks 3-6 in the absence of disease progression or unacceptable toxicity.
SURGERY/SURVEILLANCE: Patients without complete response undergo standard of care surgical resection. Patients with complete response/pursue non-operative management undergo surveillance via periodic endoscopic biopsy.
Carboplatin: Given IV
Endoscopic Biopsy: Undergo endoscopic biopsy
External Beam Radiation Therapy: Undergo EBRT
Lenvatinib Mesylate: Given PO
Paclitaxel: Given IV
Pembrolizumab: Given IV
Resection: Undergo surgical resection
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemoradiation and Pembrolizumab Followed by Pembrolizumab and Lenvatinib Before Surgery for the Treatment of Non-metastatic Esophageal or Esophageal/Gastroesophageal Junction Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Chemoradiation, Pembrolizumab, Lenvatinib)
n=3 Participants
CHEMORADIATION PHASE: Patients receive carboplatin IV and paclitaxel IV QW for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo EBRT over 6 weeks and receive pembrolizumab IV over 30 minutes on day 1 of radiation therapy in the absence of disease progression or unacceptable toxicity.
WINDOW PERIOD: Patients receive pembrolizumab IV over 30 minutes on day 1 of week 3 and lenvatinib mesylate PO QD at weeks 3-6 in the absence of disease progression or unacceptable toxicity.
SURGERY/SURVEILLANCE: Patients without complete response undergo standard of care surgical resection. Patients with complete response/pursue non-operative management undergo surveillance via periodic endoscopic biopsy.
Carboplatin: Given IV
Endoscopic Biopsy: Undergo endoscopic biopsy
External Beam Radiation Therapy: Undergo EBRT
Lenvatinib Mesylate: Given PO
Paclitaxel: Given IV
Pembrolizumab: Given IV
Resection: Undergo surgical resection
|
|---|---|
|
Age, Continuous
|
72 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: At 14 weeks after starting protocol chemoradiotherapyPopulation: The study was closed to accrual due to slow/low accrual.
Defined as no residual cancer cells, including lymph nodes under pathologic examination of the surgically resected specimen and/or a Tumor Regression Score of 0 by the College of American Pathologist (CAP) Cancer Protocol for Esophageal Carcinoma. Pathological CR rate will be estimated by the proportion of patients achieving pathological CR, along with the 95% exact binomial confidence interval.
Outcome measures
| Measure |
Treatment (Chemoradiation, Pembrolizumab, Lenvatinib)
n=3 Participants
CHEMORADIATION PHASE: Patients receive carboplatin IV and paclitaxel IV QW for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo EBRT over 6 weeks and receive pembrolizumab IV over 30 minutes on day 1 of radiation therapy in the absence of disease progression or unacceptable toxicity.
WINDOW PERIOD: Patients receive pembrolizumab IV over 30 minutes on day 1 of week 3 and lenvatinib mesylate PO QD at weeks 3-6 in the absence of disease progression or unacceptable toxicity.
SURGERY/SURVEILLANCE: Patients without complete response undergo standard of care surgical resection. Patients with complete response/pursue non-operative management undergo surveillance via periodic endoscopic biopsy.
Carboplatin: Given IV
Endoscopic Biopsy: Undergo endoscopic biopsy
External Beam Radiation Therapy: Undergo EBRT
Lenvatinib Mesylate: Given PO
Paclitaxel: Given IV
Pembrolizumab: Given IV
Resection: Undergo surgical resection
|
|---|---|
|
Pathological Complete Response (CR)
|
0 Participants
|
PRIMARY outcome
Timeframe: At 14 weeks after starting protocol chemoradiotherapyPopulation: The study was closed to accrual due to slow/low accrual.
Defined as no radiographic evidence of disease on positron emission tomography /computed tomography or CT imaging. Clinical CR rate will be estimated by the proportion of patients achieving clinical CR, along with the 95% exact binomial confidence interval.
Outcome measures
| Measure |
Treatment (Chemoradiation, Pembrolizumab, Lenvatinib)
n=3 Participants
CHEMORADIATION PHASE: Patients receive carboplatin IV and paclitaxel IV QW for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo EBRT over 6 weeks and receive pembrolizumab IV over 30 minutes on day 1 of radiation therapy in the absence of disease progression or unacceptable toxicity.
WINDOW PERIOD: Patients receive pembrolizumab IV over 30 minutes on day 1 of week 3 and lenvatinib mesylate PO QD at weeks 3-6 in the absence of disease progression or unacceptable toxicity.
SURGERY/SURVEILLANCE: Patients without complete response undergo standard of care surgical resection. Patients with complete response/pursue non-operative management undergo surveillance via periodic endoscopic biopsy.
Carboplatin: Given IV
Endoscopic Biopsy: Undergo endoscopic biopsy
External Beam Radiation Therapy: Undergo EBRT
Lenvatinib Mesylate: Given PO
Paclitaxel: Given IV
Pembrolizumab: Given IV
Resection: Undergo surgical resection
|
|---|---|
|
Clinical Complete Response (CR)
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: The study was closed to accrual due to slow/low accrual.
For each patient, tumor cytotoxic T cell infiltration will be compared between the post-chemoradiation biopsy (pre-pembrolizumab/lenvatinib) and post-treatment (definitive surgery or follow up biopsies if clinical CR) via increased expression of the 18 gene proimmune response signature measured using the Nanostring platform on tumor tissue biopsies. Participants who had changes in these measures during and after treatment will be summarized by descriptive statistics.
Outcome measures
| Measure |
Treatment (Chemoradiation, Pembrolizumab, Lenvatinib)
n=3 Participants
CHEMORADIATION PHASE: Patients receive carboplatin IV and paclitaxel IV QW for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo EBRT over 6 weeks and receive pembrolizumab IV over 30 minutes on day 1 of radiation therapy in the absence of disease progression or unacceptable toxicity.
WINDOW PERIOD: Patients receive pembrolizumab IV over 30 minutes on day 1 of week 3 and lenvatinib mesylate PO QD at weeks 3-6 in the absence of disease progression or unacceptable toxicity.
SURGERY/SURVEILLANCE: Patients without complete response undergo standard of care surgical resection. Patients with complete response/pursue non-operative management undergo surveillance via periodic endoscopic biopsy.
Carboplatin: Given IV
Endoscopic Biopsy: Undergo endoscopic biopsy
External Beam Radiation Therapy: Undergo EBRT
Lenvatinib Mesylate: Given PO
Paclitaxel: Given IV
Pembrolizumab: Given IV
Resection: Undergo surgical resection
|
|---|---|
|
Number of Participants With Immune-mediated Tumor Cytotoxicity
|
0 Participants
|
SECONDARY outcome
Timeframe: Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy, an average of 49 days.Assessed per Common Terminology Criteria for Adverse Events version 5.0.
Outcome measures
| Measure |
Treatment (Chemoradiation, Pembrolizumab, Lenvatinib)
n=3 Participants
CHEMORADIATION PHASE: Patients receive carboplatin IV and paclitaxel IV QW for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo EBRT over 6 weeks and receive pembrolizumab IV over 30 minutes on day 1 of radiation therapy in the absence of disease progression or unacceptable toxicity.
WINDOW PERIOD: Patients receive pembrolizumab IV over 30 minutes on day 1 of week 3 and lenvatinib mesylate PO QD at weeks 3-6 in the absence of disease progression or unacceptable toxicity.
SURGERY/SURVEILLANCE: Patients without complete response undergo standard of care surgical resection. Patients with complete response/pursue non-operative management undergo surveillance via periodic endoscopic biopsy.
Carboplatin: Given IV
Endoscopic Biopsy: Undergo endoscopic biopsy
External Beam Radiation Therapy: Undergo EBRT
Lenvatinib Mesylate: Given PO
Paclitaxel: Given IV
Pembrolizumab: Given IV
Resection: Undergo surgical resection
|
|---|---|
|
Number of Participants With Adverse Events
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 3 years. From initiation of treatment to the first occurrence of cancer relapse or death from any cause.Population: The study was closed to accrual due to slow/low accrual.
DFS will be determined using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Chemoradiation, Pembrolizumab, Lenvatinib)
n=3 Participants
CHEMORADIATION PHASE: Patients receive carboplatin IV and paclitaxel IV QW for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo EBRT over 6 weeks and receive pembrolizumab IV over 30 minutes on day 1 of radiation therapy in the absence of disease progression or unacceptable toxicity.
WINDOW PERIOD: Patients receive pembrolizumab IV over 30 minutes on day 1 of week 3 and lenvatinib mesylate PO QD at weeks 3-6 in the absence of disease progression or unacceptable toxicity.
SURGERY/SURVEILLANCE: Patients without complete response undergo standard of care surgical resection. Patients with complete response/pursue non-operative management undergo surveillance via periodic endoscopic biopsy.
Carboplatin: Given IV
Endoscopic Biopsy: Undergo endoscopic biopsy
External Beam Radiation Therapy: Undergo EBRT
Lenvatinib Mesylate: Given PO
Paclitaxel: Given IV
Pembrolizumab: Given IV
Resection: Undergo surgical resection
|
|---|---|
|
Disease-free Survival (DFS)
|
NA months
Median (95% CI) DFS is not reached due to the insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 3 years. From start of treatment to time of death.Population: The study was closed to accrual due to slow/low accrual.
OS will be determined using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Chemoradiation, Pembrolizumab, Lenvatinib)
n=3 Participants
CHEMORADIATION PHASE: Patients receive carboplatin IV and paclitaxel IV QW for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo EBRT over 6 weeks and receive pembrolizumab IV over 30 minutes on day 1 of radiation therapy in the absence of disease progression or unacceptable toxicity.
WINDOW PERIOD: Patients receive pembrolizumab IV over 30 minutes on day 1 of week 3 and lenvatinib mesylate PO QD at weeks 3-6 in the absence of disease progression or unacceptable toxicity.
SURGERY/SURVEILLANCE: Patients without complete response undergo standard of care surgical resection. Patients with complete response/pursue non-operative management undergo surveillance via periodic endoscopic biopsy.
Carboplatin: Given IV
Endoscopic Biopsy: Undergo endoscopic biopsy
External Beam Radiation Therapy: Undergo EBRT
Lenvatinib Mesylate: Given PO
Paclitaxel: Given IV
Pembrolizumab: Given IV
Resection: Undergo surgical resection
|
|---|---|
|
Overall Survival (OS)
|
NA months
Median (95% CI) OS is not reached due to the insufficient number of participants with events.
|
Adverse Events
Treatment (Chemoradiation, Pembrolizumab, Lenvatinib)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Chemoradiation, Pembrolizumab, Lenvatinib)
n=3 participants at risk
CHEMORADIATION PHASE: Patients receive carboplatin IV and paclitaxel IV QW for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo EBRT over 6 weeks and receive pembrolizumab IV over 30 minutes on day 1 of radiation therapy in the absence of disease progression or unacceptable toxicity.
WINDOW PERIOD: Patients receive pembrolizumab IV over 30 minutes on day 1 of week 3 and lenvatinib mesylate PO QD at weeks 3-6 in the absence of disease progression or unacceptable toxicity.
SURGERY/SURVEILLANCE: Patients without complete response undergo standard of care surgical resection. Patients with complete response/pursue non-operative management undergo surveillance via periodic endoscopic biopsy.
Carboplatin: Given IV
Endoscopic Biopsy: Undergo endoscopic biopsy
External Beam Radiation Therapy: Undergo EBRT
Lenvatinib Mesylate: Given PO
Paclitaxel: Given IV
Pembrolizumab: Given IV
Resection: Undergo surgical resection
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
3/3 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Platelet count Increased
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
3/3 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Esophagitis
|
100.0%
3/3 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Oral pain
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Non-cardiac chest pain
|
33.3%
1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Immune system disorders
mediated colitis
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
COVID 19
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
3/3 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophil count decreased
|
100.0%
3/3 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
White blood cell decreased
|
100.0%
3/3 • Number of events 14 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Appetit Change
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
1/3 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
1/3 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
3/3 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Glucosuria
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Hematuria
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urinary retention
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nose Dryness
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath on exertion
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Raches- Bilateral arms
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Rashes- Back
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Rashes- Bilateral Posterior legs
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 90 days post-last dose of protocol therapy. All-Cause Mortality was assessed from start of treatment to time of death, up to 3 years.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place