Trial Outcomes & Findings for PVSRIPO for Patients With Unresectable Melanoma (NCT NCT03712358)
NCT ID: NCT03712358
Last Updated: 2024-09-19
Results Overview
To characterize the safety and tolerability of PVSRIPO in American Joint Committee on Cancer (AJCC) Stage IIIB, IIIC, or IV melanoma.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
24 months
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Cohort 0 (PVSRIPO)
A single dose of 1.0 x 10\^8 TCID50 PVSRIPO into a single lesion.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 1 (PVSRIPO)
A single dose of 1.0 x 10\^8 TCID50 PVSRIPO into 2 different lesions, 21 days apart, when applicable per dose escalation guidelines.Total dose 2.0 x 10\^8 TCID50.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 2 (PVSRIPO)
A single dose of 1.0 x 10\^8 TCID50 PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines. Total dose 3.0 x 10\^8 TCID50.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 3 (PVSRIPO)
A single dose of 1.0 x 10\^8 TCID50 PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines. Total dose of 3.0 x 10\^8 TCID50 PVSRIPO.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 4 (PVSRIPO)
A single dose of 1.0 x 10\^8 TCID50 PVSRIPO into a single lesion, followed by PVSRIPO injected into up to 6 lesions at Day 10 and every 21 days thereafter.
PVSRIPO: Intralesional injection of PVSRIPO.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
0
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PVSRIPO for Patients With Unresectable Melanoma
Baseline characteristics by cohort
| Measure |
Cohort 0 (PVSRIPO)
n=3 Participants
A single dose of PVSRIPO into a single lesion.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 1 (PVSRIPO)
n=3 Participants
A single dose of PVSRIPO into 2 different lesions, 21 days apart, when applicable per dose escalation guidelines.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 2 (PVSRIPO)
n=3 Participants
A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 3 (PVSRIPO)
n=3 Participants
A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 4 (PVSRIPO)
A single dose of PVSRIPO into a single lesion, followed by PVSRIPO injected into up to 6 lesions at Day 10 and every 21 days thereafter.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 10.69 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 19.55 • n=7 Participants
|
70.3 years
STANDARD_DEVIATION 4.62 • n=5 Participants
|
71.0 years
STANDARD_DEVIATION 7.81 • n=4 Participants
|
—
|
65.4 years
STANDARD_DEVIATION 11.64 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
—
|
4 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
—
|
8 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
—
|
12 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
—
|
12 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Study closed to enrollment due to business decision prior to enrolling Cohort 4.
To characterize the safety and tolerability of PVSRIPO in American Joint Committee on Cancer (AJCC) Stage IIIB, IIIC, or IV melanoma.
Outcome measures
| Measure |
Cohort 0 (PVSRIPO)
n=3 Participants
A single dose of PVSRIPO into a single lesion.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 1 (PVSRIPO)
n=3 Participants
A single dose of PVSRIPO into 2 different lesions, 21 days apart, when applicable per dose escalation guidelines.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 2 (PVSRIPO)
n=3 Participants
A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 3 (PVSRIPO)
n=3 Participants
A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 4 (PVSRIPO)
A single dose of PVSRIPO into a single lesion, followed by PVSRIPO injected into up to 6 lesions at Day 10 and every 21 days thereafter.
PVSRIPO: Intralesional injection of PVSRIPO.
|
|---|---|---|---|---|---|
|
Proportion of Patients With Dose Limiting Toxicity by Cohort
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 monthsPopulation: Based on immune-related response criteria (irRC).
To describe the response rates via lesion size of PVSRIPO-injected versus non-injected lesion(s) as defined per the investigator using immune related response criteria (irRC).
Outcome measures
| Measure |
Cohort 0 (PVSRIPO)
n=3 Participants
A single dose of PVSRIPO into a single lesion.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 1 (PVSRIPO)
n=3 Participants
A single dose of PVSRIPO into 2 different lesions, 21 days apart, when applicable per dose escalation guidelines.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 2 (PVSRIPO)
n=3 Participants
A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 3 (PVSRIPO)
n=3 Participants
A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 4 (PVSRIPO)
A single dose of PVSRIPO into a single lesion, followed by PVSRIPO injected into up to 6 lesions at Day 10 and every 21 days thereafter.
PVSRIPO: Intralesional injection of PVSRIPO.
|
|---|---|---|---|---|---|
|
Response Rates Via Measurement of Cutaneous Lesions Every 3 Weeks
immune-related Partial Response (irPR)
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
—
|
|
Response Rates Via Measurement of Cutaneous Lesions Every 3 Weeks
Not Evaluable
|
3 participants
|
3 participants
|
1 participants
|
1 participants
|
—
|
|
Response Rates Via Measurement of Cutaneous Lesions Every 3 Weeks
immune related Stable Disease (irSD)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4.1 monthsPopulation: Cohort 4 not enrolled
To describe the number of CD8 positive T cells present in the tumor biopsies before and after injection of PVSRIPO.
Outcome measures
| Measure |
Cohort 0 (PVSRIPO)
n=3 Participants
A single dose of PVSRIPO into a single lesion.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 1 (PVSRIPO)
n=3 Participants
A single dose of PVSRIPO into 2 different lesions, 21 days apart, when applicable per dose escalation guidelines.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 2 (PVSRIPO)
n=3 Participants
A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 3 (PVSRIPO)
n=3 Participants
A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 4 (PVSRIPO)
A single dose of PVSRIPO into a single lesion, followed by PVSRIPO injected into up to 6 lesions at Day 10 and every 21 days thereafter.
PVSRIPO: Intralesional injection of PVSRIPO.
|
|---|---|---|---|---|---|
|
Number of CD8 Positive T Cells by Immunohistochemistry on Pre Treatment and Post Treatment Biopsy (Cohorts 0-3 Only)
Pre-treatment · Sparse
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of CD8 Positive T Cells by Immunohistochemistry on Pre Treatment and Post Treatment Biopsy (Cohorts 0-3 Only)
Post-treatment · Absent
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of CD8 Positive T Cells by Immunohistochemistry on Pre Treatment and Post Treatment Biopsy (Cohorts 0-3 Only)
Post-treatment · Sparse
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of CD8 Positive T Cells by Immunohistochemistry on Pre Treatment and Post Treatment Biopsy (Cohorts 0-3 Only)
Post-treatment · Missing data
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of CD8 Positive T Cells by Immunohistochemistry on Pre Treatment and Post Treatment Biopsy (Cohorts 0-3 Only)
Pre-treatment · Absent
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of CD8 Positive T Cells by Immunohistochemistry on Pre Treatment and Post Treatment Biopsy (Cohorts 0-3 Only)
Pre-treatment · Dense
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of CD8 Positive T Cells by Immunohistochemistry on Pre Treatment and Post Treatment Biopsy (Cohorts 0-3 Only)
Pre-treatment · Missing data
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of CD8 Positive T Cells by Immunohistochemistry on Pre Treatment and Post Treatment Biopsy (Cohorts 0-3 Only)
Post-treatment · Dense
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4.1 monthsPopulation: Insufficient sample for analysis and Cohort 4 not enrolled
Determine the pathologic response in tumor biopsies after PVSRIPO by confirming presence or absence of viable tumor cells.
Outcome measures
| Measure |
Cohort 0 (PVSRIPO)
n=2 Participants
A single dose of PVSRIPO into a single lesion.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 1 (PVSRIPO)
n=3 Participants
A single dose of PVSRIPO into 2 different lesions, 21 days apart, when applicable per dose escalation guidelines.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 2 (PVSRIPO)
n=3 Participants
A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 3 (PVSRIPO)
n=3 Participants
A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 4 (PVSRIPO)
A single dose of PVSRIPO into a single lesion, followed by PVSRIPO injected into up to 6 lesions at Day 10 and every 21 days thereafter.
PVSRIPO: Intralesional injection of PVSRIPO.
|
|---|---|---|---|---|---|
|
The Change in Tumor Pathology From Baseline to After PVSRIPO Injection
Missing data
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
The Change in Tumor Pathology From Baseline to After PVSRIPO Injection
No response
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
The Change in Tumor Pathology From Baseline to After PVSRIPO Injection
Complete response
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4.1 monthsPopulation: Insufficient sample for analysis and Cohort 4 not enrolled
Determine viral replication via a number of methods (e.g., qRT-PCR, ICH).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 4.1 monthsPopulation: Data were not collected for this measure
Determine changes in the tumor microenvironment from biopsies after PVSRIPO; includes but not limited to examination of CD8, PVR (CD155), PD-L1, CD4, FoxPE, and PD-1.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 monthsPopulation: Cohort 3 missing data; Cohort 4 not enrolled
Describe how systemic immune cell populations may change after treatment with PVSRIPO.
Outcome measures
| Measure |
Cohort 0 (PVSRIPO)
n=3 Participants
A single dose of PVSRIPO into a single lesion.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 1 (PVSRIPO)
n=3 Participants
A single dose of PVSRIPO into 2 different lesions, 21 days apart, when applicable per dose escalation guidelines.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 2 (PVSRIPO)
n=3 Participants
A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 3 (PVSRIPO)
A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 4 (PVSRIPO)
A single dose of PVSRIPO into a single lesion, followed by PVSRIPO injected into up to 6 lesions at Day 10 and every 21 days thereafter.
PVSRIPO: Intralesional injection of PVSRIPO.
|
|---|---|---|---|---|---|
|
Change Relative to Baseline in Type and/or Function of T Cells Via Flow Cytometry (Cohorts 0-3 Only)
Pre-treatment
|
10315 cells per 200,000 events
Interval 799.0 to 18923.0
|
7879 cells per 200,000 events
Interval 725.0 to 13932.0
|
39776 cells per 200,000 events
Interval 10557.0 to 86395.0
|
—
|
—
|
|
Change Relative to Baseline in Type and/or Function of T Cells Via Flow Cytometry (Cohorts 0-3 Only)
Post-treatment
|
5949 cells per 200,000 events
Interval 903.0 to 10996.0
|
20574 cells per 200,000 events
Interval 9452.0 to 31697.0
|
102332 cells per 200,000 events
Interval 55708.0 to 148957.0
|
—
|
—
|
Adverse Events
Cohort 0 (PVSRIPO)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 1 (PVSRIPO)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2 (PVSRIPO)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3 (PVSRIPO)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4 (PVSRIPO)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 0 (PVSRIPO)
n=3 participants at risk
A single dose of PVSRIPO into a single lesion.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 1 (PVSRIPO)
n=3 participants at risk
A single dose of PVSRIPO into 2 different lesions, 21 days apart, when applicable per dose escalation guidelines.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 2 (PVSRIPO)
n=3 participants at risk
A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 3 (PVSRIPO)
n=3 participants at risk
A single dose of PVSRIPO into 3 different lesions, 21 days apart, when applicable per dose escalation guidelines.
PVSRIPO: Intralesional injection of PVSRIPO.
|
Cohort 4 (PVSRIPO)
A single dose of PVSRIPO into a single lesion, followed by PVSRIPO injected into up to 6 lesions at Day 10 and every 21 days thereafter.
PVSRIPO: Intralesional injection of PVSRIPO.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
diarrhoea
|
33.3%
1/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
0.00%
0/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
33.3%
1/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
0.00%
0/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
—
0/0 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
|
Surgical and medical procedures
incisional drainage
|
33.3%
1/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
33.3%
1/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
0.00%
0/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
0.00%
0/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
—
0/0 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
0.00%
0/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
0.00%
0/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
33.3%
1/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
33.3%
1/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
—
0/0 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
|
Skin and subcutaneous tissue disorders
rash macro-papular
|
33.3%
1/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
0.00%
0/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
33.3%
1/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
0.00%
0/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
—
0/0 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
|
General disorders
pruritis
|
33.3%
1/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
66.7%
2/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
66.7%
2/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
66.7%
2/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
—
0/0 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
|
Skin and subcutaneous tissue disorders
erythema
|
33.3%
1/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
33.3%
1/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
100.0%
3/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
33.3%
1/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
—
0/0 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
|
Metabolism and nutrition disorders
decreased appetite
|
0.00%
0/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
0.00%
0/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
66.7%
2/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
33.3%
1/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
—
0/0 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
0.00%
0/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
33.3%
1/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
33.3%
1/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
—
0/0 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
33.3%
1/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
0.00%
0/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
33.3%
1/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
0.00%
0/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
—
0/0 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
0.00%
0/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
66.7%
2/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
0.00%
0/3 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
—
0/0 • From signing the informed consent form until the participant's end of study visit, up to 2 years
The # of participants at risk in Cohort 4 is zero because the study closed to enrollment due to business decision prior to enrolling Cohort 4.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60