Trial Outcomes & Findings for Pembrolizumab and Palliative Radiation Therapy in Treating Patients With Metastatic Esophagus, Stomach, or Gastroesophageal Junction Cancer (NCT NCT02830594)
NCT ID: NCT02830594
Last Updated: 2024-02-20
Results Overview
Multicolor immunofluorescence was performed to quantitate analogous CPS expression in pre- and posttreatment biopsies. Difference in MIDS expression between pre- and posttreatment was tested using a Paired T-test.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Baseline to 105 weeks
Results posted on
2024-02-20
Participant Flow
Participant milestones
| Measure |
Treatment (Pembrolizumab, RT)
INITIAL TREATMENT: Patients undergo palliative external beam RT daily. On day 1, patients undergo the first RT fraction and then receive pembrolizumab intravenously (IV) over 30 minutes. Cycles repeat every 3 weeks for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
SECOND PHASE: Patients who achieve a complete response, stop study treatment, and then experience radiographic disease progression may be eligible for the second phase at the discretion of the investigator if no cancer treatment was administered since the last dose of pembrolizumab and trial eligibility safety parameters are met. Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
External Beam Radiation Therapy: Undergo palliative external beam radiation therapy
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab and Palliative Radiation Therapy in Treating Patients With Metastatic Esophagus, Stomach, or Gastroesophageal Junction Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Pembrolizumab, RT)
n=14 Participants
INITIAL TREATMENT: Patients undergo palliative external beam RT daily. On day 1, patients undergo the first RT fraction and then receive pembrolizumab intravenously (IV) over 30 minutes. Cycles repeat every 3 weeks for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
SECOND PHASE: Patients who achieve a complete response, stop study treatment, and then experience radiographic disease progression may be eligible for the second phase at the discretion of the investigator if no cancer treatment was administered since the last dose of pembrolizumab and trial eligibility safety parameters are met. Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
External Beam Radiation Therapy: Undergo palliative external beam radiation therapy
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 105 weeksPopulation: One patient did not undergo any biopsies due to site of metastasis not being visualized under image guidance and 2 patients did not undergo the second biopsy for patient safety. Four patients had posttreatment biopsies without any viable cancer cells but only residual stromal tissue.
Multicolor immunofluorescence was performed to quantitate analogous CPS expression in pre- and posttreatment biopsies. Difference in MIDS expression between pre- and posttreatment was tested using a Paired T-test.
Outcome measures
| Measure |
Treatment (Pembrolizumab, RT)
n=7 Participants
INITIAL TREATMENT: Patients undergo palliative external beam RT daily. On day 1, patients undergo the first RT fraction and then receive pembrolizumab intravenously (IV) over 30 minutes. Cycles repeat every 3 weeks for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
SECOND PHASE: Patients who achieve a complete response, stop study treatment, and then experience radiographic disease progression may be eligible for the second phase at the discretion of the investigator if no cancer treatment was administered since the last dose of pembrolizumab and trial eligibility safety parameters are met. Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
External Beam Radiation Therapy: Undergo palliative external beam radiation therapy
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Changes in Combined Positive Scoring (CPS) in Non-irradiated Sites Assessed by Flow Cytometry
|
3.9 fold change
Standard Error 7.0
|
PRIMARY outcome
Timeframe: Baseline to 105 weeksPopulation: One patient did not undergo any biopsies due to site of metastasis not being visualized under image guidance and 2 patients did not undergo the second biopsy for patient safety. Four patients had posttreatment biopsies without any viable cancer cells but only residual stromal tissue.
Multicolor immunofluorescence was performed to quantitate analogous TPS expression in pre- and posttreatment biopsies. Difference in MIDS expression between pre- and posttreatment was tested using a Paired T-test.
Outcome measures
| Measure |
Treatment (Pembrolizumab, RT)
n=7 Participants
INITIAL TREATMENT: Patients undergo palliative external beam RT daily. On day 1, patients undergo the first RT fraction and then receive pembrolizumab intravenously (IV) over 30 minutes. Cycles repeat every 3 weeks for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
SECOND PHASE: Patients who achieve a complete response, stop study treatment, and then experience radiographic disease progression may be eligible for the second phase at the discretion of the investigator if no cancer treatment was administered since the last dose of pembrolizumab and trial eligibility safety parameters are met. Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
External Beam Radiation Therapy: Undergo palliative external beam radiation therapy
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Changes in Tumor Proportion Scores (TPS) in Non-irradiated Sites Assessed by Flow Cytometry
|
0.3 fold change
Standard Error 1.7
|
PRIMARY outcome
Timeframe: Baseline to 105 weeksPopulation: One patient did not undergo any biopsies due to site of metastasis not being visualized under image guidance and 2 patients did not undergo the second biopsy for patient safety. Four patients had posttreatment biopsies without any viable cancer cells but only residual stromal tissue.
Multicolor immunofluorescence was performed to quantitate analogous MIDS expression in pre- and posttreatment biopsies. Difference in MIDS expression between pre- and posttreatment was tested using a Paired T-test.
Outcome measures
| Measure |
Treatment (Pembrolizumab, RT)
n=7 Participants
INITIAL TREATMENT: Patients undergo palliative external beam RT daily. On day 1, patients undergo the first RT fraction and then receive pembrolizumab intravenously (IV) over 30 minutes. Cycles repeat every 3 weeks for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
SECOND PHASE: Patients who achieve a complete response, stop study treatment, and then experience radiographic disease progression may be eligible for the second phase at the discretion of the investigator if no cancer treatment was administered since the last dose of pembrolizumab and trial eligibility safety parameters are met. Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
External Beam Radiation Therapy: Undergo palliative external beam radiation therapy
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Changes in Myeloid-derived Suppressor Cells (MDSC) in Non-irradiated Sites Assessed by Flow Cytometry
|
3.6 fold change
Standard Error 7.2
|
SECONDARY outcome
Timeframe: Up to 36 monthsGraded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Adverse events with incidence greater than 10%. An adverse event is any untoward medical experience or change of an existing condition that occurs during or after treatment, whether or not it is considered to be related to the protocol intervention. Serious Adverse Events as: Death; Is life-threatening experience (places the subject at immediate risk of death from the event as it occurred); Unplanned hospitalization (equal to or greater than 24 hours) or prolongation of existing hospitalization; A persistent or significant disability/incapacity; A congenital anomaly/birth defect; Secondary malignancy; Any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject's health and may require medical or surgical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
Treatment (Pembrolizumab, RT)
n=14 Participants
INITIAL TREATMENT: Patients undergo palliative external beam RT daily. On day 1, patients undergo the first RT fraction and then receive pembrolizumab intravenously (IV) over 30 minutes. Cycles repeat every 3 weeks for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
SECOND PHASE: Patients who achieve a complete response, stop study treatment, and then experience radiographic disease progression may be eligible for the second phase at the discretion of the investigator if no cancer treatment was administered since the last dose of pembrolizumab and trial eligibility safety parameters are met. Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
External Beam Radiation Therapy: Undergo palliative external beam radiation therapy
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Incidence of Treatment Related Adverse Events of Pembrolizumab
Grade 1-2 Fatigue
|
4 participants
|
|
Incidence of Treatment Related Adverse Events of Pembrolizumab
Grade 1-2 Pruritus
|
4 participants
|
|
Incidence of Treatment Related Adverse Events of Pembrolizumab
Grade 1-2 Pneumonitis
|
2 participants
|
|
Incidence of Treatment Related Adverse Events of Pembrolizumab
Grade 1-2 Skin Rash
|
2 participants
|
|
Incidence of Treatment Related Adverse Events of Pembrolizumab
Grade 1-2 Constipation
|
2 participants
|
|
Incidence of Treatment Related Adverse Events of Pembrolizumab
Grade 1-2 Xerostomia
|
2 participants
|
|
Incidence of Treatment Related Adverse Events of Pembrolizumab
Grade 1-2 Thrombocytopenia
|
2 participants
|
|
Incidence of Treatment Related Adverse Events of Pembrolizumab
Grade 3-4 Diarrhea
|
1 participants
|
|
Incidence of Treatment Related Adverse Events of Pembrolizumab
Grade 3-4 Enterocolitis
|
1 participants
|
SECONDARY outcome
Timeframe: Up to 36 monthsResponse was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune related (ir)RECIST. Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment (Pembrolizumab, RT)
n=14 Participants
INITIAL TREATMENT: Patients undergo palliative external beam RT daily. On day 1, patients undergo the first RT fraction and then receive pembrolizumab intravenously (IV) over 30 minutes. Cycles repeat every 3 weeks for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
SECOND PHASE: Patients who achieve a complete response, stop study treatment, and then experience radiographic disease progression may be eligible for the second phase at the discretion of the investigator if no cancer treatment was administered since the last dose of pembrolizumab and trial eligibility safety parameters are met. Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
External Beam Radiation Therapy: Undergo palliative external beam radiation therapy
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Overall Response Rate (ORR)
|
28.6 percentage of participants
Interval 8.4 to 58.1
|
SECONDARY outcome
Timeframe: Up to 36 monthsEstimated using the product-limit method of Kaplan and Meier. Event defined as progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. irPD defined as a minimum 20% increase and minimum 5 mm absolute increase in TMTB compared to nadir, or irPD for non-target or new non-measurable lesions. Confirmation of progression is recommended minimum 4 weeks after the first irPD assessment.
Outcome measures
| Measure |
Treatment (Pembrolizumab, RT)
n=14 Participants
INITIAL TREATMENT: Patients undergo palliative external beam RT daily. On day 1, patients undergo the first RT fraction and then receive pembrolizumab intravenously (IV) over 30 minutes. Cycles repeat every 3 weeks for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
SECOND PHASE: Patients who achieve a complete response, stop study treatment, and then experience radiographic disease progression may be eligible for the second phase at the discretion of the investigator if no cancer treatment was administered since the last dose of pembrolizumab and trial eligibility safety parameters are met. Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
External Beam Radiation Therapy: Undergo palliative external beam radiation therapy
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Progression-free Survival (PFS)
|
1.3 Months
Interval 1.1 to
NA - The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
SECONDARY outcome
Timeframe: Up to 36 monthsEstimated using the product-limit method of Kaplan and Meier. Event defined as death from any cause.
Outcome measures
| Measure |
Treatment (Pembrolizumab, RT)
n=14 Participants
INITIAL TREATMENT: Patients undergo palliative external beam RT daily. On day 1, patients undergo the first RT fraction and then receive pembrolizumab intravenously (IV) over 30 minutes. Cycles repeat every 3 weeks for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
SECOND PHASE: Patients who achieve a complete response, stop study treatment, and then experience radiographic disease progression may be eligible for the second phase at the discretion of the investigator if no cancer treatment was administered since the last dose of pembrolizumab and trial eligibility safety parameters are met. Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
External Beam Radiation Therapy: Undergo palliative external beam radiation therapy
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Overall Survival (OS)
|
3.7 Months
Interval 2.0 to 26.2
|
Adverse Events
Treatment (Pembrolizumab, RT)
Serious events: 9 serious events
Other events: 14 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Treatment (Pembrolizumab, RT)
n=14 participants at risk
INITIAL TREATMENT: Patients undergo palliative external beam RT daily. On day 1, patients undergo the first RT fraction and then receive pembrolizumab intravenously (IV) over 30 minutes. Cycles repeat every 3 weeks for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
SECOND PHASE: Patients who achieve a complete response, stop study treatment, and then experience radiographic disease progression may be eligible for the second phase at the discretion of the investigator if no cancer treatment was administered since the last dose of pembrolizumab and trial eligibility safety parameters are met. Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
External Beam Radiation Therapy: Undergo palliative external beam radiation therapy
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
14.3%
2/14 • Number of events 2 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Pericardial effusion
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
14.3%
2/14 • Number of events 2 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Enterocolitis
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Lung infection
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Sepsis
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Blood bilirubin increased
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Thromboembolic event
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Other adverse events
| Measure |
Treatment (Pembrolizumab, RT)
n=14 participants at risk
INITIAL TREATMENT: Patients undergo palliative external beam RT daily. On day 1, patients undergo the first RT fraction and then receive pembrolizumab intravenously (IV) over 30 minutes. Cycles repeat every 3 weeks for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
SECOND PHASE: Patients who achieve a complete response, stop study treatment, and then experience radiographic disease progression may be eligible for the second phase at the discretion of the investigator if no cancer treatment was administered since the last dose of pembrolizumab and trial eligibility safety parameters are met. Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
External Beam Radiation Therapy: Undergo palliative external beam radiation therapy
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
35.7%
5/14 • Number of events 34 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - O
|
7.1%
1/14 • Number of events 2 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
7.1%
1/14 • Number of events 6 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Pericardial effusion
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
2/14 • Number of events 3 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
4/14 • Number of events 7 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
2/14 • Number of events 27 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
21.4%
3/14 • Number of events 4 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
14.3%
2/14 • Number of events 8 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Esophagitis
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Flatulence
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Mucositis oral
|
7.1%
1/14 • Number of events 2 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
35.7%
5/14 • Number of events 6 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
2/14 • Number of events 3 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Edema limbs
|
14.3%
2/14 • Number of events 3 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
57.1%
8/14 • Number of events 23 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Infusion related reaction
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"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
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Pain
|
7.1%
1/14 • Number of events 3 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Infections and infestations - Other, spe
|
14.3%
2/14 • Number of events 2 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alkaline phosphatase increased
|
21.4%
3/14 • Number of events 6 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
2/14 • Number of events 2 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Blood bilirubin increased
|
14.3%
2/14 • Number of events 3 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophil count decreased
|
7.1%
1/14 • Number of events 18 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelet count decreased
|
14.3%
2/14 • Number of events 11 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
White blood cell decreased
|
7.1%
1/14 • Number of events 16 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
21.4%
3/14 • Number of events 4 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
21.4%
3/14 • Number of events 3 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.1%
1/14 • Number of events 2 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
7.1%
1/14 • Number of events 2 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
57.1%
8/14 • Number of events 16 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
28.6%
4/14 • Number of events 6 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
57.1%
8/14 • Number of events 18 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.1%
1/14 • Number of events 2 • Adverse events occurred over a period of 41 months.
"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
|
21.4%
3/14 • Number of events 13 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue di
|
14.3%
2/14 • Number of events 4 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Number of events 2 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dysphasia
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Nervous system disorders - Other, specif
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
2/14 • Number of events 36 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Confusion
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.1%
1/14 • Number of events 23 • Adverse events occurred over a period of 41 months.
"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
|
14.3%
2/14 • Number of events 3 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
14.3%
2/14 • Number of events 3 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
28.6%
4/14 • Number of events 13 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
14.3%
2/14 • Number of events 18 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.1%
1/14 • Number of events 2 • Adverse events occurred over a period of 41 months.
"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 and subcutaneous tissue disorders -
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypertension
|
7.1%
1/14 • Number of events 11 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypotension
|
14.3%
2/14 • Number of events 24 • Adverse events occurred over a period of 41 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • Adverse events occurred over a period of 41 months.
"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