Trial Outcomes & Findings for Intravesical Administration of rAd-IFN/Syn3 in Patients With BCG-Refractory or Relapsed Bladder Cancer (NCT NCT01687244)
NCT ID: NCT01687244
Last Updated: 2017-07-24
Results Overview
Following the initial treatment, patients were clinically evaluated and re-treated at the Days 90, 180, and 270 time points, as outlined below. The decision to repeat treatment was determined by the clinical response observed following the previous treatment(s). Patients were assessed for High-Grade disease recurrence by cytology, cystoscopy and, if clinically indicated, biopsies were performed to obtain accurate staging. If no evidence of recurrence of High-Grade disease was detected, then a further dose of rAd-IFN/Syn3 was administered as maintenance therapy. Patients who had recurrence of High-Grade disease were withdrawn from treatment but were followed for survival and time to cystectomy. At 360 Days, a final efficacy evaluation was performed for patients receiving 4 doses of drug. This included cystoscopy, cytology, and biopsy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
360 Days
Results posted on
2017-07-24
Participant Flow
Participant milestones
| Measure |
rAd-IFN Dose 1x10^11vps/ml
Patients were randomized to the 1x10\^11vps/ml rAd-IFN/Syn3 arm.
A 75 mL dose of rAd-IFN/Syn3 was given as a single, one-hour intravesical administration and, depending on clinical response, was repeated every 90 Days up to a maximum of 4 instilations.
|
rAd-IFN Dose 3x10^11 Vps/ml
Patients were randomized to the 3x10\^11vps/ml rAd-IFN/Syn3 arm.
A 75 mL dose of rAd-IFN/Syn3 was given as a single, one-hour intravesical administration and, depending on clinical response, was repeated every 90 Days up to a maximum of 4 instilations.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intravesical Administration of rAd-IFN/Syn3 in Patients With BCG-Refractory or Relapsed Bladder Cancer
Baseline characteristics by cohort
| Measure |
rAd-IFN Dose 1x10^11vps/ml
n=21 Participants
Patients were randomly assigned to the 1x10\^11vps/ml of rAd-IFN/Syn3 arm.
|
rAd-IFN Dose 3x10^11 Vps/ml
n=19 Participants
Patients were randomly assigned to the 3x10\^11vps/ml of rAd-IFN/Syn3 arm.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Continuous
|
71.6 years
STANDARD_DEVIATION 8.07 • n=5 Participants
|
71.1 years
STANDARD_DEVIATION 9.42 • n=7 Participants
|
71.1 years
STANDARD_DEVIATION 9.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 360 DaysFollowing the initial treatment, patients were clinically evaluated and re-treated at the Days 90, 180, and 270 time points, as outlined below. The decision to repeat treatment was determined by the clinical response observed following the previous treatment(s). Patients were assessed for High-Grade disease recurrence by cytology, cystoscopy and, if clinically indicated, biopsies were performed to obtain accurate staging. If no evidence of recurrence of High-Grade disease was detected, then a further dose of rAd-IFN/Syn3 was administered as maintenance therapy. Patients who had recurrence of High-Grade disease were withdrawn from treatment but were followed for survival and time to cystectomy. At 360 Days, a final efficacy evaluation was performed for patients receiving 4 doses of drug. This included cystoscopy, cytology, and biopsy.
Outcome measures
| Measure |
rAd-IFN Dose 1x10^11 Vps/ml
n=21 Participants
Subjects were randomly assigned to the 1x10\^11 vps/mI rAd-IFN/Syn3 arm.
|
rAd-IFN Dose 3x10^11vps/ml
n=19 Participants
Patients were randomly assigned to the 3x10\^11vps/ml rAd-IFN/Syn3 arm.
|
|---|---|---|
|
Incidence of High Grade-Recurrence Free Survival at 360 Days
|
7 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 360 DaysTreatment Emergent Adverse Events (AEs) for patients receiving study drug were described by NCI-CTCAE V4.03 terminology according to System Organ Class.
Outcome measures
| Measure |
rAd-IFN Dose 1x10^11 Vps/ml
n=21 Participants
Subjects were randomly assigned to the 1x10\^11 vps/mI rAd-IFN/Syn3 arm.
|
rAd-IFN Dose 3x10^11vps/ml
n=19 Participants
Patients were randomly assigned to the 3x10\^11vps/ml rAd-IFN/Syn3 arm.
|
|---|---|---|
|
Safety of rAd-IFN/Syn3
|
20 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 90 DaysPopulation: All patients at 90 Days were assessed for High-Grade disease by cytology, cystoscopy, and biopsy if clinically indicated.
All patients were evaluated 3 Months (90 Days) after the start of treatment for recurrence of high grade disease by cytology, cystoscopy, and biopsy if clinically indicated. Patients that we free of High-Grade disease recurrence received another dose. Data are presented as the number and percent of patients with High-Grade disease recurrence.
Outcome measures
| Measure |
rAd-IFN Dose 1x10^11 Vps/ml
n=21 Participants
Subjects were randomly assigned to the 1x10\^11 vps/mI rAd-IFN/Syn3 arm.
|
rAd-IFN Dose 3x10^11vps/ml
n=19 Participants
Patients were randomly assigned to the 3x10\^11vps/ml rAd-IFN/Syn3 arm.
|
|---|---|---|
|
Incidence of High Grade Recurrence-Free Survival at 3 Months (90 Days).
|
10 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 180 DaysPopulation: All patients receiving a dose at 90 Days were assessed at 180 Days for High-Grade disease by cytology, cystoscopy, and biopsy if clinically indicated.
All patients were evaluated 6 Months (180 Days) after the start of treatment for recurrence of high grade disease by cytology, cystoscopy, and biopsy if clinically indicated. Patients that we free of High-Grade disease recurrence received another dose. Data are presented as the number and percent of patients with High-Grade disease recurrence.
Outcome measures
| Measure |
rAd-IFN Dose 1x10^11 Vps/ml
n=21 Participants
Subjects were randomly assigned to the 1x10\^11 vps/mI rAd-IFN/Syn3 arm.
|
rAd-IFN Dose 3x10^11vps/ml
n=19 Participants
Patients were randomly assigned to the 3x10\^11vps/ml rAd-IFN/Syn3 arm.
|
|---|---|---|
|
Incidence of High Grade-Recurrence-Free Survival at 6 Months (180 Days).
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 270 DaysPopulation: All patients that received a dose at Day 180 were assessed for High-Grade disease by cytology, cystoscopy, and biopsy if clinically indicated.
All patients were evaluated 9 Months (270 Days) after the start of treatment for recurrence of high grade disease by cytology, cystoscopy, and biopsy if clinically indicated. Patients that we free of High-Grade disease recurrence received a final dose. Data are presented as the number and percent of patients with High-Grade disease recurrence.
Outcome measures
| Measure |
rAd-IFN Dose 1x10^11 Vps/ml
n=21 Participants
Subjects were randomly assigned to the 1x10\^11 vps/mI rAd-IFN/Syn3 arm.
|
rAd-IFN Dose 3x10^11vps/ml
n=19 Participants
Patients were randomly assigned to the 3x10\^11vps/ml rAd-IFN/Syn3 arm.
|
|---|---|---|
|
Incidence of High Grade-Recurrence-Free Survival at 9 Months (270 Days).
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 360 DaysPopulation: The data are presented as the number of patients per dose group having a cystectomy during the 360 days of the study.
This secondary objective measures the incidence of cystectomy at 360 Days for the Efficacy Analysis Set.
Outcome measures
| Measure |
rAd-IFN Dose 1x10^11 Vps/ml
n=21 Participants
Subjects were randomly assigned to the 1x10\^11 vps/mI rAd-IFN/Syn3 arm.
|
rAd-IFN Dose 3x10^11vps/ml
n=19 Participants
Patients were randomly assigned to the 3x10\^11vps/ml rAd-IFN/Syn3 arm.
|
|---|---|---|
|
Incidence of Cystectomy in All Patients
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 360 DaysPopulation: The data are presented as the number of patients who survived the study (360 Days). All patients were monitored for this endpoint.
Overall survival was defined as the number who survived from the first dose of rAd-IFN/Syn3 to the end of the primary assessment (360 Days) or Withdrawal.
Outcome measures
| Measure |
rAd-IFN Dose 1x10^11 Vps/ml
n=21 Participants
Subjects were randomly assigned to the 1x10\^11 vps/mI rAd-IFN/Syn3 arm.
|
rAd-IFN Dose 3x10^11vps/ml
n=19 Participants
Patients were randomly assigned to the 3x10\^11vps/ml rAd-IFN/Syn3 arm.
|
|---|---|---|
|
Overall Survival in All Patients.
|
21 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 103 DaysPopulation: Data are reported as number of patients demonstrating viral vector by qPCR in blood.
The level of viral vector as measured by qPCR in blood was determined in all patients on the initial day of dosing Day 1 (pre-dose) and at Day 2, Day 4, Day 12, and for patients that were free of High-Grade disease recurrence and received a second dose at Day 91 (pre-dose), Day 92, Day 94, and Day 103.
Outcome measures
| Measure |
rAd-IFN Dose 1x10^11 Vps/ml
n=21 Participants
Subjects were randomly assigned to the 1x10\^11 vps/mI rAd-IFN/Syn3 arm.
|
rAd-IFN Dose 3x10^11vps/ml
n=19 Participants
Patients were randomly assigned to the 3x10\^11vps/ml rAd-IFN/Syn3 arm.
|
|---|---|---|
|
Number of Patients With Elevated Levels of Viral Vector in Blood
Pre-Dose Day 1
|
0 Participants
|
0 Participants
|
|
Number of Patients With Elevated Levels of Viral Vector in Blood
Day 12
|
0 Participants
|
0 Participants
|
|
Number of Patients With Elevated Levels of Viral Vector in Blood
Pre-Dose Day 91
|
0 Participants
|
0 Participants
|
|
Number of Patients With Elevated Levels of Viral Vector in Blood
Day 92
|
0 Participants
|
0 Participants
|
|
Number of Patients With Elevated Levels of Viral Vector in Blood
Day 2
|
0 Participants
|
0 Participants
|
|
Number of Patients With Elevated Levels of Viral Vector in Blood
Day 4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Elevated Levels of Viral Vector in Blood
Day 94
|
0 Participants
|
0 Participants
|
|
Number of Patients With Elevated Levels of Viral Vector in Blood
Day 103
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 103 DaysPopulation: Data are reported as number of patients demonstrating increased levels of viral vector by qPCR in urine.
The level of viral vector as measured by qPCR in urine was determined in all patients on the initial day of dosing Day 1 (pre-dose) and at Day 2, Day 4, Day 12, and for patients that were free of High-Grade disease recurrence and received a second dose at Day 91 (pre-dose), Day 92, Day 94, and Day 103.
Outcome measures
| Measure |
rAd-IFN Dose 1x10^11 Vps/ml
n=21 Participants
Subjects were randomly assigned to the 1x10\^11 vps/mI rAd-IFN/Syn3 arm.
|
rAd-IFN Dose 3x10^11vps/ml
n=19 Participants
Patients were randomly assigned to the 3x10\^11vps/ml rAd-IFN/Syn3 arm.
|
|---|---|---|
|
Number of Patients With Elevated Levels of Viral Vector in Urine
Pre-Dose Day 1
|
1 Participants
|
0 Participants
|
|
Number of Patients With Elevated Levels of Viral Vector in Urine
Pre-Dose Day 91
|
1 Participants
|
2 Participants
|
|
Number of Patients With Elevated Levels of Viral Vector in Urine
Day 103
|
2 Participants
|
4 Participants
|
|
Number of Patients With Elevated Levels of Viral Vector in Urine
Day 2
|
21 Participants
|
18 Participants
|
|
Number of Patients With Elevated Levels of Viral Vector in Urine
Day 4
|
20 Participants
|
19 Participants
|
|
Number of Patients With Elevated Levels of Viral Vector in Urine
Day 12
|
17 Participants
|
16 Participants
|
|
Number of Patients With Elevated Levels of Viral Vector in Urine
Day 92
|
10 Participants
|
11 Participants
|
|
Number of Patients With Elevated Levels of Viral Vector in Urine
Day 94
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 360 DaysPopulation: Data are reported as the number of patients with increased levels of IFN alpha2b protein in serum.
The levels of serum IFN alpha2b protein as measured by ELISA were determined in all patients on the initial day of dosing (Pre-Dose Day 1), at Day 2, Day 4, Day 12, and for patients that were free of High-Grade disease recurrence and received subsequent doses at Day 91 (pre-dose), Day 92, Day 94, Day 103, Day 180 (pre-dose), Day 270 (pre-dose), and Day 360 or Withdrawal.
Outcome measures
| Measure |
rAd-IFN Dose 1x10^11 Vps/ml
n=21 Participants
Subjects were randomly assigned to the 1x10\^11 vps/mI rAd-IFN/Syn3 arm.
|
rAd-IFN Dose 3x10^11vps/ml
n=19 Participants
Patients were randomly assigned to the 3x10\^11vps/ml rAd-IFN/Syn3 arm.
|
|---|---|---|
|
Number of Patients With Elevated IFN alpha2b Protein Levels in Serum
Pre-Dose Day 1
|
1 Participants
|
1 Participants
|
|
Number of Patients With Elevated IFN alpha2b Protein Levels in Serum
Day 4
|
1 Participants
|
6 Participants
|
|
Number of Patients With Elevated IFN alpha2b Protein Levels in Serum
Day 12
|
1 Participants
|
1 Participants
|
|
Number of Patients With Elevated IFN alpha2b Protein Levels in Serum
Day 91
|
1 Participants
|
1 Participants
|
|
Number of Patients With Elevated IFN alpha2b Protein Levels in Serum
Pre-Dose Day 270
|
0 Participants
|
0 Participants
|
|
Number of Patients With Elevated IFN alpha2b Protein Levels in Serum
Day 360 or Withdrawal
|
0 Participants
|
0 Participants
|
|
Number of Patients With Elevated IFN alpha2b Protein Levels in Serum
Day 2
|
2 Participants
|
10 Participants
|
|
Number of Patients With Elevated IFN alpha2b Protein Levels in Serum
Day 92
|
1 Participants
|
1 Participants
|
|
Number of Patients With Elevated IFN alpha2b Protein Levels in Serum
Day 94
|
1 Participants
|
1 Participants
|
|
Number of Patients With Elevated IFN alpha2b Protein Levels in Serum
Day 103
|
1 Participants
|
1 Participants
|
|
Number of Patients With Elevated IFN alpha2b Protein Levels in Serum
Pre-Dose Day 180
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 103 DaysPopulation: Data are reported as the number of patients with elevated levels of IFN alpha2b levels in urine.
The levels of urine IFN alpha2b protein as measured by ELISA were measured in all patients on the initial day of dosing Day 1 (pre-dose) and at Day 2, Day 4, Day 12, and for patients that did not have recurrence of HGD and received a second dose at Day 91 (pre-dose), Day 92, Day 94, and Day 103.
Outcome measures
| Measure |
rAd-IFN Dose 1x10^11 Vps/ml
n=21 Participants
Subjects were randomly assigned to the 1x10\^11 vps/mI rAd-IFN/Syn3 arm.
|
rAd-IFN Dose 3x10^11vps/ml
n=19 Participants
Patients were randomly assigned to the 3x10\^11vps/ml rAd-IFN/Syn3 arm.
|
|---|---|---|
|
Number of Patients With Elevated IFN alpha2b Protein Levels in Urine
Pre-Dose Day 1
|
0 Participants
|
0 Participants
|
|
Number of Patients With Elevated IFN alpha2b Protein Levels in Urine
Day 2
|
21 Participants
|
18 Participants
|
|
Number of Patients With Elevated IFN alpha2b Protein Levels in Urine
Pre-Dose Day 91
|
0 Participants
|
0 Participants
|
|
Number of Patients With Elevated IFN alpha2b Protein Levels in Urine
Day 92
|
8 Participants
|
9 Participants
|
|
Number of Patients With Elevated IFN alpha2b Protein Levels in Urine
Day 94
|
5 Participants
|
3 Participants
|
|
Number of Patients With Elevated IFN alpha2b Protein Levels in Urine
Day 103
|
0 Participants
|
0 Participants
|
|
Number of Patients With Elevated IFN alpha2b Protein Levels in Urine
Day 4
|
17 Participants
|
18 Participants
|
|
Number of Patients With Elevated IFN alpha2b Protein Levels in Urine
Day 12
|
1 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 360 DaysPopulation: Data are reported at Number of Patients with a Positive Titre.
The levels of serum anti-IFN alpha2b antibodies as measured by ELISA were determined in all patients on the initial day of dosing (Pre-Dose Day 1), at Day 12, and for patients that were free of High-Grade disease recurrence and received subsequent doses at Day 180 (pre-dose), Day 270 (pre-dose), and Day 360 or Withdrawal.
Outcome measures
| Measure |
rAd-IFN Dose 1x10^11 Vps/ml
n=21 Participants
Subjects were randomly assigned to the 1x10\^11 vps/mI rAd-IFN/Syn3 arm.
|
rAd-IFN Dose 3x10^11vps/ml
n=19 Participants
Patients were randomly assigned to the 3x10\^11vps/ml rAd-IFN/Syn3 arm.
|
|---|---|---|
|
Number of Patients With Elevated Levels of Anti-IFN alpha2b Antibodies in Serum
Pre-Dose Day 1
|
0 Participants
|
0 Participants
|
|
Number of Patients With Elevated Levels of Anti-IFN alpha2b Antibodies in Serum
Day 12
|
0 Participants
|
1 Participants
|
|
Number of Patients With Elevated Levels of Anti-IFN alpha2b Antibodies in Serum
Pre-Dose Day 180
|
0 Participants
|
0 Participants
|
|
Number of Patients With Elevated Levels of Anti-IFN alpha2b Antibodies in Serum
Pre-Dose Day 270
|
0 Participants
|
0 Participants
|
|
Number of Patients With Elevated Levels of Anti-IFN alpha2b Antibodies in Serum
Day 360 or Withdrawal
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 360 DaysPopulation: Data are reported at Number of Patients with a Positive Titer.
The levels of serum anti-adenovirus type 5 antibodies as measured by ELISA were determined in all patients on the initial day of dosing (Pre-Dose Day 1), at Day 12, and for patients that were free of High-Grade disease recurrence and received subsequent subsequent doses at Day 180 (pre-dose), Day 270 (pre-dose), and Day 360 or Withdrawal.
Outcome measures
| Measure |
rAd-IFN Dose 1x10^11 Vps/ml
n=21 Participants
Subjects were randomly assigned to the 1x10\^11 vps/mI rAd-IFN/Syn3 arm.
|
rAd-IFN Dose 3x10^11vps/ml
n=19 Participants
Patients were randomly assigned to the 3x10\^11vps/ml rAd-IFN/Syn3 arm.
|
|---|---|---|
|
Number of Patients With Elevated Levels of Anti-Adenovirus Type 5 Antibodies in Serum.
Pre-Dose Day 1
|
0 Participants
|
0 Participants
|
|
Number of Patients With Elevated Levels of Anti-Adenovirus Type 5 Antibodies in Serum.
Day 12
|
2 Participants
|
1 Participants
|
|
Number of Patients With Elevated Levels of Anti-Adenovirus Type 5 Antibodies in Serum.
Pre-Dose Day 180
|
6 Participants
|
6 Participants
|
|
Number of Patients With Elevated Levels of Anti-Adenovirus Type 5 Antibodies in Serum.
Pre-Dose Day 270
|
6 Participants
|
5 Participants
|
|
Number of Patients With Elevated Levels of Anti-Adenovirus Type 5 Antibodies in Serum.
Day 360 or Withdrawal
|
12 Participants
|
7 Participants
|
Adverse Events
rAd-IFN Dose 1x10^11 Vps/ml
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
rAd-IFN Dose 3x10^11vps/ml
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
rAd-IFN Dose 1x10^11 Vps/ml
n=21 participants at risk
Patients were randomized to the 1x10\^11 vps/ml INSTILADRIN arm.
|
rAd-IFN Dose 3x10^11vps/ml
n=19 participants at risk
Patients were randomized the 3x10\^11 vps/ml INSTILADRIN arm.
|
|---|---|---|
|
Nervous system disorders
Syncope
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Infections and infestations
Sepsis
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Cardiac disorders
Coronary artery occlusion
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Nervous system disorders
Carotid artery occlusion
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Surgical and medical procedures
Nephroureterectomy
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
Other adverse events
| Measure |
rAd-IFN Dose 1x10^11 Vps/ml
n=21 participants at risk
Patients were randomized to the 1x10\^11 vps/ml INSTILADRIN arm.
|
rAd-IFN Dose 3x10^11vps/ml
n=19 participants at risk
Patients were randomized the 3x10\^11 vps/ml INSTILADRIN arm.
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
9.5%
2/21 • Number of events 2 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Eye disorders
Blurred Vision
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
10.5%
2/19 • Number of events 2 • From dosing day 1 up to 12 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
10.5%
2/19 • Number of events 2 • From dosing day 1 up to 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
3/21 • Number of events 3 • From dosing day 1 up to 12 months
|
10.5%
2/19 • Number of events 2 • From dosing day 1 up to 12 months
|
|
Gastrointestinal disorders
Frequent Bowel Movements
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Gastrointestinal disorders
Nausea
|
14.3%
3/21 • Number of events 3 • From dosing day 1 up to 12 months
|
15.8%
3/19 • Number of events 3 • From dosing day 1 up to 12 months
|
|
Gastrointestinal disorders
Oesophageal Dilatation
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Gastrointestinal disorders
Vomiting
|
9.5%
2/21 • Number of events 2 • From dosing day 1 up to 12 months
|
10.5%
2/19 • Number of events 2 • From dosing day 1 up to 12 months
|
|
General disorders
Asthenia
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
10.5%
2/19 • Number of events 2 • From dosing day 1 up to 12 months
|
|
General disorders
Chest pain
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
General disorders
Chills
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
36.8%
7/19 • Number of events 7 • From dosing day 1 up to 12 months
|
|
General disorders
Facial Pain
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
General disorders
Fatique
|
28.6%
6/21 • Number of events 6 • From dosing day 1 up to 12 months
|
36.8%
7/19 • Number of events 7 • From dosing day 1 up to 12 months
|
|
General disorders
Feeling Cold
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
General disorders
Influenza Like Illness
|
9.5%
2/21 • Number of events 2 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
General disorders
Infusion Site Reactions
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
General disorders
Malaise
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
General disorders
Pain
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
General disorders
Pyrexia
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
31.6%
6/19 • Number of events 6 • From dosing day 1 up to 12 months
|
|
Infections and infestations
Bronchitis
|
9.5%
2/21 • Number of events 2 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Infections and infestations
Cystitis
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Infections and infestations
Gasteroenteritis
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Infections and infestations
Influenza
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
10.5%
2/19 • Number of events 2 • From dosing day 1 up to 12 months
|
|
Infections and infestations
Nasophanryngitis
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Infections and infestations
Pneumonia
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Infections and infestations
Sepsis
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Infections and infestations
Skin Infection
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Infections and infestations
Urinary Tract Infection
|
14.3%
3/21 • Number of events 3 • From dosing day 1 up to 12 months
|
26.3%
5/19 • Number of events 5 • From dosing day 1 up to 12 months
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Injury, poisoning and procedural complications
Contusion
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Injury, poisoning and procedural complications
Laceration
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Investigations
Blood Creatinine Increase
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Investigations
Glycosylated Hemoglobin Increase
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Investigations
pH Urine Decreased
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Investigations
Urine Output DeEcreased
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Metabolism and nutrition disorders
Fluid Retention
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.5%
2/21 • Number of events 2 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Metabolism and nutrition disorders
Oedemia Peripheral
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
2/21 • Number of events 2 • From dosing day 1 up to 12 months
|
10.5%
2/19 • Number of events 2 • From dosing day 1 up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
10.5%
2/19 • Number of events 2 • From dosing day 1 up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Intervertrebral Disc Degeneration
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Joint Range of Motion Decreased
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo Maligno Stage Unspecified
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Neoplasm
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic Keratosis
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Nervous system disorders
Carotid Artery Occlusion
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Nervous system disorders
Carotid Artery Stenosis
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Nervous system disorders
Dizziness
|
9.5%
2/21 • Number of events 2 • From dosing day 1 up to 12 months
|
21.1%
4/19 • Number of events 4 • From dosing day 1 up to 12 months
|
|
Nervous system disorders
Encephalopathy
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Nervous system disorders
Headache
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Nervous system disorders
Lethargy
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Nervous system disorders
Restless Leg Syndrome
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Nervous system disorders
Sinus Headache
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
10.5%
2/19 • Number of events 2 • From dosing day 1 up to 12 months
|
|
Nervous system disorders
Syncope
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Psychiatric disorders
Mental Status Change
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Renal and urinary disorders
Bladder Discomfort
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Renal and urinary disorders
Bladder Pain
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
15.8%
3/19 • Number of events 3 • From dosing day 1 up to 12 months
|
|
Renal and urinary disorders
Bladder Perforation
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Renal and urinary disorders
Dysuria
|
42.9%
9/21 • Number of events 9 • From dosing day 1 up to 12 months
|
36.8%
7/19 • Number of events 7 • From dosing day 1 up to 12 months
|
|
Renal and urinary disorders
Hematuria
|
23.8%
5/21 • Number of events 5 • From dosing day 1 up to 12 months
|
26.3%
5/19 • Number of events 5 • From dosing day 1 up to 12 months
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Renal and urinary disorders
Micturition Urgency
|
47.6%
10/21 • Number of events 10 • From dosing day 1 up to 12 months
|
31.6%
6/19 • Number of events 6 • From dosing day 1 up to 12 months
|
|
Renal and urinary disorders
Nocturia
|
23.8%
5/21 • Number of events 5 • From dosing day 1 up to 12 months
|
26.3%
5/19 • Number of events 5 • From dosing day 1 up to 12 months
|
|
Renal and urinary disorders
Pollakiuria
|
28.6%
6/21 • Number of events 6 • From dosing day 1 up to 12 months
|
26.3%
5/19 • Number of events 5 • From dosing day 1 up to 12 months
|
|
Renal and urinary disorders
Polyuria
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Renal and urinary disorders
Renal Failure
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Renal and urinary disorders
Renal Pain
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Renal and urinary disorders
Urethral Stenosis
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Renal and urinary disorders
Urinary Incontinence
|
14.3%
3/21 • Number of events 3 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Renal and urinary disorders
Urinary Retention
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Renal and urinary disorders
Urinary Tract Disorder
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Renal and urinary disorders
Urine Flow Decreased
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Reproductive system and breast disorders
Prostatic Hemorrhage
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
9.5%
2/21 • Number of events 2 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
9.5%
2/21 • Number of events 2 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Skin and subcutaneous tissue disorders
Erythemia
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Skin and subcutaneous tissue disorders
Hyperhydrosis
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Surgical and medical procedures
Nephroureterectomy
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Vascular disorders
Aortic Stenosis
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Vascular disorders
Arterial Hemorrhage
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Vascular disorders
Hypertension
|
9.5%
2/21 • Number of events 2 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Vascular disorders
Hypotension
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Endocrine disorders
Hypothyroidism
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
|
Ear and labyrinth disorders
Eye Pain
|
0.00%
0/21 • From dosing day 1 up to 12 months
|
5.3%
1/19 • Number of events 1 • From dosing day 1 up to 12 months
|
|
Cardiac disorders
Coronary Artery Occlusion
|
4.8%
1/21 • Number of events 1 • From dosing day 1 up to 12 months
|
0.00%
0/19 • From dosing day 1 up to 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor will complete its review within the review period and will have authority to require that the Institution and/or Investigator delete from the disclosure of any reference to Confidential Information, other than results.
- Publication restrictions are in place
Restriction type: OTHER