Trial Outcomes & Findings for VSV-hIFNbeta-NIS With or Without Ruxolitinib Phosphate in Treating Stage IV or Recurrent Endometrial Cancer (NCT NCT03120624)
NCT ID: NCT03120624
Last Updated: 2026-02-04
Results Overview
Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4. DLT is defined as one of the following events deemed related to the study drug; Grade 2+ allergic reaction or cytokine release syndrome, or any grade 3+ with the exception of lymphopenia or other related events (e.g., anemia, white blood cell count decreased), which will not be considered a dose limiting toxicity. Grade ≥3 flu-like symptoms, fever, nausea, vomiting, dehydration, diarrhea, headache, myalgia, fatigue, ALT increased, or AST increased, will also not be considered as a dose limiting toxicity as they are anticipated toxicities of treatment.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
28 days
Results posted on
2026-02-04
Participant Flow
Participant milestones
| Measure |
Cohort A Dose Level 1
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort A Dose Level 2
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort A Dose Level 3
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort A Dose Level 4
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort B Dose Level 1
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
Cohort B Dose Level 2
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
Cohort B Dose Level 3
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
Cohort B Dose Level 4
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
10
|
3
|
6
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
9
|
3
|
6
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort A Dose Level 1
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort A Dose Level 2
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort A Dose Level 3
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort A Dose Level 4
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort B Dose Level 1
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
Cohort B Dose Level 2
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
Cohort B Dose Level 3
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
Cohort B Dose Level 4
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
VSV-hIFNbeta-NIS With or Without Ruxolitinib Phosphate in Treating Stage IV or Recurrent Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Cohort A Dose Level 1
n=3 Participants
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort A Dose Level 2
n=9 Participants
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort A Dose Level 3
n=3 Participants
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort A Dose Level 4
n=6 Participants
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort B Dose Level 1
n=3 Participants
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
Cohort B Dose Level 2
n=3 Participants
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
Cohort B Dose Level 3
n=3 Participants
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
Cohort B Dose Level 4
n=3 Participants
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 8.14 • n=41 Participants
|
65.6 years
STANDARD_DEVIATION 7 • n=1581 Participants
|
62.7 years
STANDARD_DEVIATION 5.03 • n=4626 Participants
|
60.2 years
STANDARD_DEVIATION 16.3 • n=72 Participants
|
66 years
STANDARD_DEVIATION 11.53 • n=11 Participants
|
68.3 years
STANDARD_DEVIATION 2.08 • n=19 Participants
|
67 years
STANDARD_DEVIATION 2.65 • n=58 Participants
|
63.7 years
STANDARD_DEVIATION 6.43 • n=25 Participants
|
63.5 years
STANDARD_DEVIATION 9.38 • n=13 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=41 Participants
|
9 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
6 Participants
n=72 Participants
|
3 Participants
n=11 Participants
|
3 Participants
n=19 Participants
|
3 Participants
n=58 Participants
|
3 Participants
n=25 Participants
|
33 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=41 Participants
|
9 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
5 Participants
n=72 Participants
|
3 Participants
n=11 Participants
|
2 Participants
n=19 Participants
|
3 Participants
n=58 Participants
|
3 Participants
n=25 Participants
|
31 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
1 Participants
n=72 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=25 Participants
|
2 Participants
n=13 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
1 Participants
n=72 Participants
|
1 Participants
n=11 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=25 Participants
|
2 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=41 Participants
|
8 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
5 Participants
n=72 Participants
|
2 Participants
n=11 Participants
|
2 Participants
n=19 Participants
|
3 Participants
n=58 Participants
|
3 Participants
n=25 Participants
|
29 Participants
n=13 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=13 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: All treated patients are included.
Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4. DLT is defined as one of the following events deemed related to the study drug; Grade 2+ allergic reaction or cytokine release syndrome, or any grade 3+ with the exception of lymphopenia or other related events (e.g., anemia, white blood cell count decreased), which will not be considered a dose limiting toxicity. Grade ≥3 flu-like symptoms, fever, nausea, vomiting, dehydration, diarrhea, headache, myalgia, fatigue, ALT increased, or AST increased, will also not be considered as a dose limiting toxicity as they are anticipated toxicities of treatment.
Outcome measures
| Measure |
Cohort A Dose Level 1
n=3 Participants
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort A Dose Level 2
n=9 Participants
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort A Dose Level 3
n=3 Participants
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort A Dose Level 4
n=6 Participants
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort B Dose Level 1
n=3 Participants
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
Cohort B Dose Level 2
n=3 Participants
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
Cohort B Dose Level 3
n=3 Participants
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
Cohort B Dose Level 4
n=3 Participants
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
|---|---|---|---|---|---|---|---|---|
|
Participants Who Experienced a Dose-limiting Toxicity (DLT)
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearGraded according to the NCI CTCAE version 4. Frequency distributions and other descriptive measures will form the basis of the analysis of these variables. Simple summary statistics will be supplemented with Kaplan-Meier survival estimates and related confidence intervals.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearDefined as complete response, partial response, or stable disease assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Will be summarized by simple descriptive summary statistics across all patients in each group as well as by dose level and primary type of cancer (EC).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearDescriptive statistics and scatterplots will form the basis of presentation of these variables. Correlations with other outcome measures will be carried out by standard parametric and non-parametric tests (e.g. Pearson's and Spearman's rho).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 daysPopulation: Tomography was only conducted on patients accrued prior to 8/6/2021 due to all of the scans failing to observe any virus spread. The burden to patients and research resources was deemed unacceptable for no scientific benefit.
Virus spread will be ssessed via single-photon emission computed tomography/computed tomography and will be correlated with tumor distribution.
Outcome measures
| Measure |
Cohort A Dose Level 1
n=3 Participants
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort A Dose Level 2
n=9 Participants
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort A Dose Level 3
n=3 Participants
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort A Dose Level 4
n=5 Participants
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort B Dose Level 1
n=3 Participants
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
Cohort B Dose Level 2
n=2 Participants
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
Cohort B Dose Level 3
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
Cohort B Dose Level 4
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
|---|---|---|---|---|---|---|---|---|
|
Count of Patients With Positive Virus Spread.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearGraded according to the NCI CTCAE version 4. Simple summary statistics will be supplemented with Kaplan-Meier survival estimates and related confidence intervals. The effect of dose and ancillary dichotomized covariates such as age will be explored using logrank testing involving one covariate at a time.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearSimple summary statistics will be supplemented with Kaplan-Meier survival estimates and related confidence intervals. The effect of dose and ancillary dichotomized covariates such as age will be explored using logrank testing involving one covariate at a time.
Outcome measures
Outcome data not reported
Adverse Events
Cohort A Dose Level 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort A Dose Level 2
Serious events: 4 serious events
Other events: 9 other events
Deaths: 7 deaths
Cohort A Dose Level 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort A Dose Level 4
Serious events: 4 serious events
Other events: 6 other events
Deaths: 4 deaths
Cohort B Dose Level 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort B Dose Level 2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort B Dose Level 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort B Dose Level 4
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort A Dose Level 1
n=3 participants at risk
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort A Dose Level 2
n=9 participants at risk
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort A Dose Level 3
n=3 participants at risk
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort A Dose Level 4
n=6 participants at risk
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort B Dose Level 1
n=3 participants at risk
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
Cohort B Dose Level 2
n=3 participants at risk
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
Cohort B Dose Level 3
n=3 participants at risk
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
Cohort B Dose Level 4
n=3 participants at risk
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 4 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 8 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
22.2%
2/9 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Nervous system disorders
Stroke
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
Other adverse events
| Measure |
Cohort A Dose Level 1
n=3 participants at risk
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort A Dose Level 2
n=9 participants at risk
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort A Dose Level 3
n=3 participants at risk
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort A Dose Level 4
n=6 participants at risk
Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.
|
Cohort B Dose Level 1
n=3 participants at risk
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
Cohort B Dose Level 2
n=3 participants at risk
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
Cohort B Dose Level 3
n=3 participants at risk
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
Cohort B Dose Level 4
n=3 participants at risk
Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
22.2%
2/9 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Investigations
Weight loss
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 4 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
2/6 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
55.6%
5/9 • Number of events 26 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 15 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
6/6 • Number of events 33 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 8 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 20 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 16 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 8 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
3/9 • Number of events 8 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
50.0%
3/6 • Number of events 9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
66.7%
2/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
88.9%
8/9 • Number of events 27 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 10 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
83.3%
5/6 • Number of events 23 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 8 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
6/9 • Number of events 19 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
2/6 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
77.8%
7/9 • Number of events 9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 4 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
83.3%
5/6 • Number of events 8 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
General disorders
Edema limbs
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 7 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 12 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
88.9%
8/9 • Number of events 30 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 22 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
83.3%
5/6 • Number of events 34 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 24 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 14 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 8 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 13 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
General disorders
Fever
|
33.3%
1/3 • Number of events 7 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
9/9 • Number of events 16 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 4 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
50.0%
3/6 • Number of events 8 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
General disorders
Malaise
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Investigations
Activated partial throm time prolonged
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
44.4%
4/9 • Number of events 16 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
83.3%
5/6 • Number of events 17 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 8 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
3/9 • Number of events 16 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 4 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 13 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
6/9 • Number of events 18 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 7 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
83.3%
5/6 • Number of events 22 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Investigations
Creatinine increased
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
44.4%
4/9 • Number of events 11 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
83.3%
5/6 • Number of events 25 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 8 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 8 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
9/9 • Number of events 39 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 19 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
6/6 • Number of events 36 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 8 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 18 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 7 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 7 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Investigations
Neutrophil count decreased
|
66.7%
2/3 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
44.4%
4/9 • Number of events 10 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
2/6 • Number of events 7 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 7 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 4 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • Number of events 9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
77.8%
7/9 • Number of events 30 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 13 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
83.3%
5/6 • Number of events 24 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 11 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Investigations
White blood cell decreased
|
33.3%
1/3 • Number of events 7 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
44.4%
4/9 • Number of events 19 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
2/6 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 4 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 10 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 7 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
2/3 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
44.4%
4/9 • Number of events 9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 4 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
22.2%
2/9 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
50.0%
3/6 • Number of events 10 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 4 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
55.6%
5/9 • Number of events 17 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
83.3%
5/6 • Number of events 15 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 13 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 8 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 11 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
22.2%
2/9 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • Number of events 4 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
3/9 • Number of events 7 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
2/6 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
22.2%
2/9 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 4 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
33.3%
1/3 • Number of events 4 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
66.7%
2/3 • Number of events 8 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
66.7%
2/3 • Number of events 8 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
2/6 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
4/6 • Number of events 14 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
50.0%
3/6 • Number of events 10 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 4 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
3/9 • Number of events 10 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
3/3 • Number of events 8 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
2/6 • Number of events 8 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 4 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 4 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
11.1%
1/9 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
33.3%
1/3 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
16.7%
1/6 • Number of events 2 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 7 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
33.3%
1/3 • Number of events 1 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
6/9 • Number of events 13 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
100.0%
6/6 • Number of events 15 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 5 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 9 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 7 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
66.7%
2/3 • Number of events 6 • Adverse events were followed for 1 year and mortality was followed for 63 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place