Trial Outcomes & Findings for Phase 1b Dose Escalation Study of Intravenous JX-594 in Metastatic, Refractory Colorectal Carcinoma (NCT NCT01380600)
NCT ID: NCT01380600
Last Updated: 2026-07-08
Results Overview
A DLT is defined as any of the following treatment-related adverse events: Grade 4 toxicity, Grade 3 hematologic toxicity for \> 5 days, or Grade 3 non-hematologic toxicities persisting for \> 7 days except for flu-like symptoms that respond to standard therapies. The number of participants with DLTs was used to determine the Maximally-Tolerated Dose (MTD) and/or Maximum-Feasible Dose (MFD) of JX-594.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Up to Day 57 (assessed through 14 days following the 4th and final biweekly JX-594 infusion, an average of 8 weeks).
Results posted on
2026-07-08
Participant Flow
Patients with metastatic, refractory colorectal carcinoma who had failed both oxaliplatin- and irinotecan-based prior chemotherapy regimens were recruited at a single study site (Samsung Medical Center) in Seoul, Republic of Korea. The recruitment and study conduct took place between September 08, 2010, and October 18, 2012
A total of 15 patients were screened for the study. All 15 screened patients (100%) met the eligibility criteria and were successfully enrolled. There were no screen failures or significant events prior to cohort assignment.
Participant milestones
| Measure |
Cohort 1: Pexa-Vec 1 × 10^6 Pfu/kg
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 1 × 10\^6 pfu/kg.
|
Cohort 2: Pexa-Vec 1 × 10^7 Pfu/kg
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 1 × 10\^7 pfu/kg.
|
Cohort 3: Pexa-Vec 3 × 10^7 Pfu/kg
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 3 × 10\^7 pfu/kg.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
9
|
|
Overall Study
COMPLETED
|
2
|
2
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ITT Population
Baseline characteristics by cohort
| Measure |
Cohort 1: Pexa-Vec 1 × 10^6 Pfu/kg
n=3 Participants
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 1 × 10\^6 pfu/kg.
|
Cohort 2: Pexa-Vec 1 × 10^7 Pfu/kg
n=3 Participants
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 1 × 10\^7 pfu/kg.
|
Cohort 3: Pexa-Vec 3 × 10^7 Pfu/kg
n=9 Participants
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 3 × 10\^7 pfu/kg.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46 Years
STANDARD_DEVIATION 13.45 • n=9 Participants
|
56.3 Years
STANDARD_DEVIATION 10.97 • n=27 Participants
|
56.7 Years
STANDARD_DEVIATION 13.15 • n=267 Participants
|
54.5 Years
STANDARD_DEVIATION 12.69 • n=265 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
5 Participants
n=265 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
10 Participants
n=265 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
15 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Region of Enrollment
South Korea
|
3 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
15 Participants
n=265 Participants
|
|
American Joint Committee on Cancer (AJCC) Staging
Stage IVA
|
2 Participants
n=9 Participants • ITT Population
|
0 Participants
n=27 Participants • ITT Population
|
0 Participants
n=267 Participants • ITT Population
|
2 Participants
n=265 Participants • ITT Population
|
|
American Joint Committee on Cancer (AJCC) Staging
Stage IVB
|
1 Participants
n=9 Participants • ITT Population
|
3 Participants
n=27 Participants • ITT Population
|
9 Participants
n=267 Participants • ITT Population
|
13 Participants
n=265 Participants • ITT Population
|
|
KRAS Mutational Status
Wild-type
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
11 Participants
n=265 Participants
|
|
KRAS Mutational Status
Mutant
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
|
KRAS Mutational Status
Not Assessed
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
|
Received Smallpox Vaccine
Yes
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
|
Received Smallpox Vaccine
No
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
|
Received Smallpox Vaccine
Unknown
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
8 Participants
n=265 Participants
|
PRIMARY outcome
Timeframe: Up to Day 57 (assessed through 14 days following the 4th and final biweekly JX-594 infusion, an average of 8 weeks).Population: The analysis population is the Intent-to-Treat (ITT) population, which includes all patients who received at least one treatment of Pexa-Vec.
A DLT is defined as any of the following treatment-related adverse events: Grade 4 toxicity, Grade 3 hematologic toxicity for \> 5 days, or Grade 3 non-hematologic toxicities persisting for \> 7 days except for flu-like symptoms that respond to standard therapies. The number of participants with DLTs was used to determine the Maximally-Tolerated Dose (MTD) and/or Maximum-Feasible Dose (MFD) of JX-594.
Outcome measures
| Measure |
Cohort 1: Pexa-Vec 1 × 10^6 Pfu/kg
n=3 Participants
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 1 × 10\^6 pfu/kg.
|
Cohort 2: Pexa-Vec 1 × 10^7 Pfu/kg
n=3 Participants
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 1 × 10\^7 pfu/kg.
|
Cohort 3: Pexa-Vec 3 × 10^7 Pfu/kg
n=9 Participants
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 3 × 10\^7 pfu/kg.
|
|---|---|---|---|
|
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 71 (assessed through 28 days following the 4th and final biweekly JX-594 infusion, an average of 10 weeks).Population: The Intent-to-Treat (ITT) population includes all patients who received at least one treatment of Pexa-Vec.
Adverse events were collected and assessed to evaluate safety and tolerability. A Treatment-Emergent Adverse Event (TEAE) is defined as an event with a start date on or after the date of the first dose of study treatment, or an event present at baseline that worsened in severity after the first dose.
Outcome measures
| Measure |
Cohort 1: Pexa-Vec 1 × 10^6 Pfu/kg
n=3 Participants
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 1 × 10\^6 pfu/kg.
|
Cohort 2: Pexa-Vec 1 × 10^7 Pfu/kg
n=3 Participants
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 1 × 10\^7 pfu/kg.
|
Cohort 3: Pexa-Vec 3 × 10^7 Pfu/kg
n=9 Participants
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 3 × 10\^7 pfu/kg.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Experienced TEAE
|
3 Participants
|
3 Participants
|
9 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Did NOT Experience TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 57 (Week 8)Population: The analysis population is the Intent-to-Treat (ITT) population, which includes all patients who received at least one treatment of Pexa-Vec.
Anti-tumoral response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) on CT or MRI. Categories include: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) = \>=30% decrease in the sum of the longest diameters of target lesions; Progressive Disease (PD) = \>=20% increase in the sum of the longest diameters of target lesions or appearance of new lesions; Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
Cohort 1: Pexa-Vec 1 × 10^6 Pfu/kg
n=3 Participants
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 1 × 10\^6 pfu/kg.
|
Cohort 2: Pexa-Vec 1 × 10^7 Pfu/kg
n=3 Participants
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 1 × 10\^7 pfu/kg.
|
Cohort 3: Pexa-Vec 3 × 10^7 Pfu/kg
n=9 Participants
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 3 × 10\^7 pfu/kg.
|
|---|---|---|---|
|
Number of Participants in Each Best Overall Tumor Response Category Based on RECIST
Partial Response
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Each Best Overall Tumor Response Category Based on RECIST
Stable Disease
|
0 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants in Each Best Overall Tumor Response Category Based on RECIST
Progressive Disease
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants in Each Best Overall Tumor Response Category Based on RECIST
No Post-Baseline Assessment
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants in Each Best Overall Tumor Response Category Based on RECIST
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the first dose of Pexa-Vec until death from any cause, assessed up to 24 monthsPopulation: The analysis population is the Intent-to-Treat (ITT) population, which includes all patients who received at least one treatment of Pexa-Vec
Overall survival (OS) was defined as the time from the first dose of Pexa-Vec until death from any cause. For patients not known to have died at the time of the analysis, OS was censored on the date they were last known to be alive.
Outcome measures
| Measure |
Cohort 1: Pexa-Vec 1 × 10^6 Pfu/kg
n=3 Participants
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 1 × 10\^6 pfu/kg.
|
Cohort 2: Pexa-Vec 1 × 10^7 Pfu/kg
n=3 Participants
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 1 × 10\^7 pfu/kg.
|
Cohort 3: Pexa-Vec 3 × 10^7 Pfu/kg
n=9 Participants
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 3 × 10\^7 pfu/kg.
|
|---|---|---|---|
|
Overall Survival (OS)
|
10.4 months
Interval 10.19 to 10.61
|
5.06 months
For Cohort 2, the Kaplan-Meier estimate for median overall survival was 5.06 months, and the calculated 95% CI was 5.91 to 19.58 months. Due to the extremely small sample size (n=3), the mathematically calculated lower bound of the 95% CI exceeded the median.
|
10.22 months
Interval 5.06 to 11.43
|
Adverse Events
Cohort 1: Pexa-Vec 1 × 10^6 Pfu/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort 2: Pexa-Vec 1 × 10^7 Pfu/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 3: Pexa-Vec 3 × 10^7 Pfu/kg
Serious events: 2 serious events
Other events: 9 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Cohort 1: Pexa-Vec 1 × 10^6 Pfu/kg
n=3 participants at risk
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 1 × 10\^6 pfu/kg.
|
Cohort 2: Pexa-Vec 1 × 10^7 Pfu/kg
n=3 participants at risk
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 1 × 10\^7 pfu/kg.
|
Cohort 3: Pexa-Vec 3 × 10^7 Pfu/kg
n=9 participants at risk
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 3 × 10\^7 pfu/kg.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
11.1%
1/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
General disorders
Disease progression
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
11.1%
1/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
Other adverse events
| Measure |
Cohort 1: Pexa-Vec 1 × 10^6 Pfu/kg
n=3 participants at risk
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 1 × 10\^6 pfu/kg.
|
Cohort 2: Pexa-Vec 1 × 10^7 Pfu/kg
n=3 participants at risk
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 1 × 10\^7 pfu/kg.
|
Cohort 3: Pexa-Vec 3 × 10^7 Pfu/kg
n=9 participants at risk
Patients received biweekly intravenous (IV) infusions of Pexa-Vec at a dose of 3 × 10\^7 pfu/kg.
|
|---|---|---|---|
|
General disorders
Pyrexia
|
100.0%
3/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
100.0%
3/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
88.9%
8/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
General disorders
Chills
|
33.3%
1/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
100.0%
3/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
100.0%
9/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
33.3%
1/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
11.1%
1/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
22.2%
2/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
11.1%
1/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
66.7%
2/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
44.4%
4/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
33.3%
3/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
33.3%
1/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
22.2%
2/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
33.3%
1/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
11.1%
1/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
11.1%
1/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
11.1%
1/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
11.1%
1/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
33.3%
1/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
General disorders
Haematochezia
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
11.1%
1/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
100.0%
3/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
44.4%
4/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
33.3%
1/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
44.4%
4/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
77.8%
7/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
11.1%
1/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
11.1%
1/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
33.3%
3/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
33.3%
1/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
11.1%
1/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
33.3%
1/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
11.1%
1/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
22.2%
2/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
11.1%
1/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
11.1%
1/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
11.1%
1/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
11.1%
1/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
11.1%
1/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
11.1%
1/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
33.3%
1/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
33.3%
3/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
33.3%
1/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
11.1%
1/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
11.1%
1/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
General disorders
Pain
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
33.3%
1/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
22.2%
2/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
0.00%
0/3 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
22.2%
2/9 • Up to approximately 24 months (from the first dose until study completion)
All summaries of adverse events include all-causality treatment-emergent adverse events (TEAEs) only, where TEAEs are defined as AEs that occurred or worsened in severity grade on or after the first treatment of Pexa-Vec, regardless of relationship to the investigational product.
|
Additional Information
Seunghyun Ma, M.D., Ph.D., Chief Medical Officer
SillaJen Biotherapeutics, Inc.
Phone: (415) 281-8886
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place