Trial Outcomes & Findings for MV-NIS Infected Mesenchymal Stem Cells in Treating Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancer (NCT NCT02068794)
NCT ID: NCT02068794
Last Updated: 2025-11-18
Results Overview
Maximum tolerated dose will be defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
34 participants
Primary outcome timeframe
28 days
Results posted on
2025-11-18
Participant Flow
Participant milestones
| Measure |
Phase I Dose Level 0
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1 of cycle 1 and 10\^7 MV-NIS infected MSC (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or MRI throughout the study.
|
Phase I Dose Level 1
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1 of cycle 1 and 10\^8 MV-NIS infected MSC (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or MRI throughout the study.
|
Phase II (Dose Level 1)
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1 of cycle 1 and 10\^8 MV-NIS infected MSC (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or MRI throughout the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
7
|
23
|
|
Overall Study
COMPLETED
|
3
|
6
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
4
|
Reasons for withdrawal
| Measure |
Phase I Dose Level 0
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1 of cycle 1 and 10\^7 MV-NIS infected MSC (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or MRI throughout the study.
|
Phase I Dose Level 1
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1 of cycle 1 and 10\^8 MV-NIS infected MSC (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or MRI throughout the study.
|
Phase II (Dose Level 1)
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1 of cycle 1 and 10\^8 MV-NIS infected MSC (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or MRI throughout the study.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
|
Overall Study
Early Progression
|
1
|
0
|
1
|
|
Overall Study
Ineligible
|
0
|
0
|
1
|
Baseline Characteristics
MV-NIS Infected Mesenchymal Stem Cells in Treating Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Baseline characteristics by cohort
| Measure |
Phase I Dose Level 0
n=3 Participants
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1 of cycle 1 and 10\^7 MV-NIS infected MSC (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or MRI throughout the study.
|
Phase I Dose Level 1
n=6 Participants
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1 of cycle 1 and 10\^8 MV-NIS infected MSC (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or MRI throughout the study.
|
Phase II (Dose Level 1)
n=20 Participants
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1 of cycle 1 and 10\^8 MV-NIS infected MSC (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or MRI throughout the study.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 12.74 • n=202 Participants
|
62.3 years
STANDARD_DEVIATION 9.11 • n=283 Participants
|
62.5 years
STANDARD_DEVIATION 8.94 • n=120 Participants
|
62.1 years
STANDARD_DEVIATION 9.03 • n=122 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=202 Participants
|
6 Participants
n=283 Participants
|
20 Participants
n=120 Participants
|
29 Participants
n=122 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
1 Participants
n=122 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=202 Participants
|
6 Participants
n=283 Participants
|
18 Participants
n=120 Participants
|
27 Participants
n=122 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
1 Participants
n=122 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
1 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=202 Participants
|
5 Participants
n=283 Participants
|
18 Participants
n=120 Participants
|
26 Participants
n=122 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
2 Participants
n=122 Participants
|
PRIMARY outcome
Timeframe: 28 daysMaximum tolerated dose will be defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients).
Outcome measures
| Measure |
Phase I and II (Dose Level 1)
n=3 Participants
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1 of cycle 1 and 10\^8 MV-NIS infected MSC (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or MRI throughout the study.
|
Phase I Dose Level 1
n=6 Participants
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1 of cycle 1 and 10\^8 MV-NIS infected MSC (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or MRI throughout the study.
|
|---|---|---|
|
Count of Participants That Experience a DLT
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Both Phase I and Phase II patients treated at dose level 1 are evaluable for this endpoint.
The proportion of patients that were followed and alive at 12 months post registration.
Outcome measures
| Measure |
Phase I and II (Dose Level 1)
n=26 Participants
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1 of cycle 1 and 10\^8 MV-NIS infected MSC (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or MRI throughout the study.
|
Phase I Dose Level 1
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1 of cycle 1 and 10\^8 MV-NIS infected MSC (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or MRI throughout the study.
|
|---|---|---|
|
Overall Survival at 12 Months
|
0.692 Proportion of patients
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsWill be defined as complete response or partial response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthsPopulation: All evaluable patients treated at the maximum tolerated dose(Dose level 1) will be included in this analysis.
Defined as the proportion of patients alive and progression free at 4 months.
Outcome measures
| Measure |
Phase I and II (Dose Level 1)
n=26 Participants
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1 of cycle 1 and 10\^8 MV-NIS infected MSC (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or MRI throughout the study.
|
Phase I Dose Level 1
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1 of cycle 1 and 10\^8 MV-NIS infected MSC (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or MRI throughout the study.
|
|---|---|---|
|
4 Month Progression Free Survival Rate
|
0.769 proportion of patients
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsDefined as the length of time from study registration to date of death due to any cause. The distribution of survival time will be estimated using Kaplan-Meier survival curves and logrank tests.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsProgression-free survival (PFS) is defined as the length of time from study registration to the first of either death due to any cause or progression. The distribution of PFS will be estimated using Kaplan-Meier survival curves and logrank tests. In addition, comparisons of overall PFS in patients treated with MV-NIS/MSC will be made to patients enrolled on the prior MV-CEA and MV-NIS trial in an exploratory manner.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsDescriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlations between these laboratory values and other outcome measures will be carried out using Spearman's coefficients, chi squared tests, Wilcoxon rank-sum tests, Kaplan-Meier curves, and Cox proportional hazards models, where appropriate.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsDescriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlations between these laboratory values and other outcome measures will be carried out using Spearman's coefficients, chi squared tests, Wilcoxon rank-sum tests, Kaplan-Meier curves, and Cox proportional hazards models, where appropriate.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsDescriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlations between these laboratory values and other outcome measures will be carried out using Spearman's coefficients, chi squared tests, Wilcoxon rank-sum tests, Kaplan-Meier curves, and Cox proportional hazards models, where appropriate.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsDescriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlations between these laboratory values and other outcome measures will be carried out using Spearman's coefficients, chi squared tests, Wilcoxon rank-sum tests, Kaplan-Meier curves, and Cox proportional hazards models, where appropriate.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsDescriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlations between these laboratory values and other outcome measures will be carried out using Spearman's coefficients, chi squared tests, Wilcoxon rank-sum tests, Kaplan-Meier curves, and Cox proportional hazards models, where appropriate.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsDescriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlations between these laboratory values and other outcome measures will be carried out using Spearman's coefficients, chi squared tests, Wilcoxon rank-sum tests, Kaplan-Meier curves, and Cox proportional hazards models, where appropriate.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsDescriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlations between these laboratory values and other outcome measures will be carried out using Spearman's coefficients, chi squared tests, Wilcoxon rank-sum tests, Kaplan-Meier curves, and Cox proportional hazards models, where appropriate.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsDescriptive statistics and simple scatterplots will form the basis of presentation of these data. Correlations between these laboratory values and other outcome measures will be carried out using Spearman's coefficients, chi squared tests, Wilcoxon rank-sum tests, Kaplan-Meier curves, and Cox proportional hazards models, where appropriate.
Outcome measures
Outcome data not reported
Adverse Events
Phase I Dose Level 0
Serious events: 0 serious events
Other events: 4 other events
Deaths: 4 deaths
Phase I Dose Level 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 5 deaths
Phase II (Dose Level 1)
Serious events: 4 serious events
Other events: 20 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Phase I Dose Level 0
n=4 participants at risk
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1 of cycle 1 and 10\^7 MV-NIS infected MSC (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or MRI throughout the study.
|
Phase I Dose Level 1
n=7 participants at risk
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1 of cycle 1 and 10\^8 MV-NIS infected MSC (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or MRI throughout the study.
|
Phase II (Dose Level 1)
n=23 participants at risk
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1 of cycle 1 and 10\^8 MV-NIS infected MSC (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or MRI throughout the study.
|
|---|---|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
0.00%
0/7 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
13.0%
3/23 • Number of events 3 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.00%
0/4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
0.00%
0/7 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
4.3%
1/23 • Number of events 1 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
0.00%
0/7 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
4.3%
1/23 • Number of events 1 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
Other adverse events
| Measure |
Phase I Dose Level 0
n=4 participants at risk
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1 of cycle 1 and 10\^7 MV-NIS infected MSC (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or MRI throughout the study.
|
Phase I Dose Level 1
n=7 participants at risk
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1 of cycle 1 and 10\^8 MV-NIS infected MSC (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or MRI throughout the study.
|
Phase II (Dose Level 1)
n=23 participants at risk
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1 of cycle 1 and 10\^8 MV-NIS infected MSC (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or MRI throughout the study.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
2/4 • Number of events 4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
57.1%
4/7 • Number of events 8 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
69.6%
16/23 • Number of events 31 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
0.00%
0/7 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
4.3%
1/23 • Number of events 1 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
42.9%
3/7 • Number of events 5 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
39.1%
9/23 • Number of events 14 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
85.7%
6/7 • Number of events 21 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
30.4%
7/23 • Number of events 12 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
28.6%
2/7 • Number of events 5 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
26.1%
6/23 • Number of events 7 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
28.6%
2/7 • Number of events 3 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
21.7%
5/23 • Number of events 5 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
General disorders
Chills
|
50.0%
2/4 • Number of events 4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
28.6%
2/7 • Number of events 8 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
17.4%
4/23 • Number of events 6 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
14.3%
1/7 • Number of events 3 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
13.0%
3/23 • Number of events 4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
General disorders
Fever
|
50.0%
2/4 • Number of events 4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
14.3%
1/7 • Number of events 4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
26.1%
6/23 • Number of events 7 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
Investigations
Activated partial throm time prolonged
|
0.00%
0/4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
0.00%
0/7 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
8.7%
2/23 • Number of events 3 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
0.00%
0/7 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
8.7%
2/23 • Number of events 2 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
0.00%
0/7 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
17.4%
4/23 • Number of events 7 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
Investigations
Neutrophil count decreased
|
25.0%
1/4 • Number of events 1 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
14.3%
1/7 • Number of events 2 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
17.4%
4/23 • Number of events 4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
14.3%
1/7 • Number of events 1 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
26.1%
6/23 • Number of events 12 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
Investigations
White blood cell decreased
|
0.00%
0/4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
28.6%
2/7 • Number of events 3 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
26.1%
6/23 • Number of events 7 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
14.3%
1/7 • Number of events 1 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
0.00%
0/23 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Number of events 1 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
0.00%
0/7 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
0.00%
0/23 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
0.00%
0/7 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
4.3%
1/23 • Number of events 1 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
0.00%
0/7 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
4.3%
1/23 • Number of events 1 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
1/4 • Number of events 1 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
0.00%
0/7 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
34.8%
8/23 • Number of events 11 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
0.00%
0/7 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
4.3%
1/23 • Number of events 1 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
0.00%
0/7 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
4.3%
1/23 • Number of events 1 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
14.3%
1/7 • Number of events 1 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
0.00%
0/23 • Adverse events were followed for 8 months and mortality was followed for 5 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place