Trial Outcomes & Findings for CAVATAK (CVA21) in Non-muscle Invasive Bladder Cancer (VLA-012 CANON) (NCT NCT02316171)
NCT ID: NCT02316171
Last Updated: 2022-07-27
Results Overview
Number of Participants with Treatment-emergent adverse events. The events for each cohort of dose of CVA21 only are pooled for the analysis.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
30 days from last dose
Results posted on
2022-07-27
Participant Flow
9 patients were enrolled into VLA012A and 6 patients into VLA012B and data presented for these 15 patients. One patient was enrolled, but not treated due to difficulties in placing the urinary catheter.
Participant milestones
| Measure |
A1 - CVA21 1x10^8 TCID50
CAVATAK was administered by intravesical instillation at 1x10\^8 TCID50.
|
CVA21/Mitomycin C
Mitomycin C (MMC) was administered at 10 mg by intravesical instillation on Day 1. Four hours after instillation of MMC, CVA21 was administered by intravesical instillation of one of 2 ascending dose levels or schedules. Subjects received a second instillation of CVA21 alone on Day 2 without pretreatment with MMC.
|
A2 - CVA21 3x10^8 TCID50.
CAVATAK was administered at 3x10\^8 TCID50
|
A3 - CVA21 3x10^8 TCID50 x2
CAVATAK was administered at 3x10\^8 TCID50 twice.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
6
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
A1 - CVA21 1x10^8 TCID50
CAVATAK was administered by intravesical instillation at 1x10\^8 TCID50.
|
CVA21/Mitomycin C
Mitomycin C (MMC) was administered at 10 mg by intravesical instillation on Day 1. Four hours after instillation of MMC, CVA21 was administered by intravesical instillation of one of 2 ascending dose levels or schedules. Subjects received a second instillation of CVA21 alone on Day 2 without pretreatment with MMC.
|
A2 - CVA21 3x10^8 TCID50.
CAVATAK was administered at 3x10\^8 TCID50
|
A3 - CVA21 3x10^8 TCID50 x2
CAVATAK was administered at 3x10\^8 TCID50 twice.
|
|---|---|---|---|---|
|
Overall Study
difficulties with urinary catheter
|
1
|
0
|
0
|
0
|
Baseline Characteristics
CAVATAK (CVA21) in Non-muscle Invasive Bladder Cancer (VLA-012 CANON)
Baseline characteristics by cohort
| Measure |
CVA21
n=9 Participants
CVA21 was administered by intravesical instillation of one of 3 ascending dose levels or schedules:
|
CVA21/MitomycinC
n=6 Participants
Mitomycin C (MMC) was administered at 10 mg by intravesical instillation on Day 1. Four hours after instillation of MMC, CVA21 was administered by intravesical instillation of one of 2 ascending dose levels or schedules. Subjects received a second instillation of CVA21 alone on Day 2 without pretreatment with MMC
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
65 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days from last doseNumber of Participants with Treatment-emergent adverse events. The events for each cohort of dose of CVA21 only are pooled for the analysis.
Outcome measures
| Measure |
CVA21
n=9 Participants
CVA21 was administered by intravesical instillation of one of 3 ascending dose levels or schedules
|
CVA21/Mitomycin C
n=6 Participants
Mitomycin C (MMC) was administered at 10 mg by intravesical instillation on Day 1. Four hours after instillation of MMC, CVA21 was administered by intravesical instillation of one of 2 ascending dose levels or schedules. Subjects received a second instillation of CVA21 alone on Day 2 without pretreatment with MMC.
|
|---|---|---|
|
Incidence of Dose-limiting Toxicities Treatment-related Adverse Events.
|
9 Participants
|
6 Participants
|
Adverse Events
CVA21
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
CVA21/Mitomycin C
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CVA21
n=9 participants at risk
CVA21 was administered by intravesical instillation of one of 3 ascending dose levels or schedules
|
CVA21/Mitomycin C
n=6 participants at risk
Mitomycin C (MMC) was administered at 10 mg by intravesical instillation on Day 1. Four hours after instillation of MMC, CVA21 was administered by intravesical instillation of one of 2 ascending dose levels or schedules. Subjects received a second instillation of CVA21 alone on Day 2 without pretreatment with MMC.
|
|---|---|---|
|
Infections and infestations
E. Coli urinary tract infection
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
Other adverse events
| Measure |
CVA21
n=9 participants at risk
CVA21 was administered by intravesical instillation of one of 3 ascending dose levels or schedules
|
CVA21/Mitomycin C
n=6 participants at risk
Mitomycin C (MMC) was administered at 10 mg by intravesical instillation on Day 1. Four hours after instillation of MMC, CVA21 was administered by intravesical instillation of one of 2 ascending dose levels or schedules. Subjects received a second instillation of CVA21 alone on Day 2 without pretreatment with MMC.
|
|---|---|---|
|
Renal and urinary disorders
Hematuria
|
55.6%
5/9 • Number of events 5 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
66.7%
4/6 • Number of events 4 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Renal and urinary disorders
Dysuria
|
55.6%
5/9 • Number of events 5 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
16.7%
1/6 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Renal and urinary disorders
Pollakiuria
|
33.3%
3/9 • Number of events 3 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
16.7%
1/6 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Renal and urinary disorders
Bladder discomfort
|
0.00%
0/9 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
16.7%
1/6 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Renal and urinary disorders
Bladder disorder
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Renal and urinary disorders
Bladder Pain
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Renal and urinary disorders
Micturition urgency
|
11.1%
1/9 • Number of events 2 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Renal and urinary disorders
Urinary incontinence
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
22.2%
2/9 • Number of events 2 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
16.7%
1/6 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Infections and infestations
Escherichia urinary tract infection
|
22.2%
2/9 • Number of events 2 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
16.7%
1/6 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
16.7%
1/6 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
16.7%
1/6 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Gastrointestinal disorders
Diverticulum
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
16.7%
1/6 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Gastrointestinal disorders
Toothache
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Investigations
Blood urea increased
|
22.2%
2/9 • Number of events 2 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Investigations
Blood uric acid increased
|
22.2%
2/9 • Number of events 2 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Investigations
Blood bilirubin increased
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Investigations
Blood glucose increased
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Investigations
Lipase increased
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Investigations
Neutrophil count increased
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Investigations
White blood cell count increased
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Investigations
White blood cells urine positive
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
General disorders
Fatigue
|
22.2%
2/9 • Number of events 2 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
General disorders
Chills
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
General disorders
Influenza like illness
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
General disorders
Pyrexia
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
3/9 • Number of events 3 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
16.7%
1/6 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.2%
2/9 • Number of events 2 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
16.7%
1/6 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Reproductive system and breast disorders
Genital discomfort
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Surgical and medical procedures
Skin neoplasm excision
|
11.1%
1/9 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
0.00%
0/6 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/9 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
16.7%
1/6 • Number of events 1 • 30 days. The analysis for each dose escalation cohort for CVA21 only was pooled as the numbers were so small. This resulted in an analysis showing 2 arms.
No SUSARs were reported for the VLA-012 study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place