Trial Outcomes & Findings for Study of Bacillus Calmette-Guerin (BCG) Combined With PANVAC Versus BCG Alone in Adults With High Grade Non-Muscle Invasive Bladder Cancer Who Failed At Least 1 Course of BCG (NCT NCT02015104)
NCT ID: NCT02015104
Last Updated: 2025-07-01
Results Overview
RFS is defined as the time from the start of intravesical Bacillus Calmette-Guerin (TICE BCG) therapy (week 3) until disease recurrence or death due to any cause in each arm. Recurrence is suspected and/or determined by urine cytology and/or cystoscopic exam and then confirmed pathologically after a transurethral resection of bladder tumor (TURBT). Positive cytology in the absence of pathologic confirmation is not considered to be a recurrence.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Assessed from start of therapy to 6 and 12 months following therapy
Results posted on
2025-07-01
Participant Flow
Participant milestones
| Measure |
Bacillus Calmette-Guerin (BCG) + PANVAC
Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks. PANVAC-V 2 x 10\^8 pfu subcutaneous (SQ) at week 0 only; PANVAC-F 1 x 10\^9 pfu SQ at weeks 3, 7, 11, and 15
TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis
PANVAC: A recombinant virus vector vaccine containing genes for human carcinoembryonic antigen (CEA), mucin-1 (MUC-1) and three co-stimulatory molecules (designated Triad of costimulatory molecules (TRICOM): B7.1, intercellular adhesion molecule-1 (ICAM-1), and leukocyte function-associated antigen-3 (LFA-3).
|
Bacillus Calmette-Guerin (BCG) Alone
Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks
TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Bacillus Calmette-Guerin (BCG) + PANVAC
Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks. PANVAC-V 2 x 10\^8 pfu subcutaneous (SQ) at week 0 only; PANVAC-F 1 x 10\^9 pfu SQ at weeks 3, 7, 11, and 15
TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis
PANVAC: A recombinant virus vector vaccine containing genes for human carcinoembryonic antigen (CEA), mucin-1 (MUC-1) and three co-stimulatory molecules (designated Triad of costimulatory molecules (TRICOM): B7.1, intercellular adhesion molecule-1 (ICAM-1), and leukocyte function-associated antigen-3 (LFA-3).
|
Bacillus Calmette-Guerin (BCG) Alone
Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks
TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis
|
|---|---|---|
|
Overall Study
Withdrew consent after first dose drug
|
1
|
0
|
|
Overall Study
Withdrew consent prior to treatment
|
0
|
1
|
Baseline Characteristics
Study of Bacillus Calmette-Guerin (BCG) Combined With PANVAC Versus BCG Alone in Adults With High Grade Non-Muscle Invasive Bladder Cancer Who Failed At Least 1 Course of BCG
Baseline characteristics by cohort
| Measure |
Bacillus Calmette-Guerin (BCG) + PANVAC
n=16 Participants
Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks. PANVAC-V 2 x 10\^8 pfu subcutaneous (SQ) at week 0 only; PANVAC-F 1 x 10\^9 pfu SQ at weeks 3, 7, 11, and 15
TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis
PANVAC:A recombinant virus vector vaccine containing genes for human carcinoembryonic antigen (CEA), mucin-1 (MUC-1) and three co-stimulatory molecules (designated Triad of costimulatory molecules (TRICOM): B7.1, intercellular adhesion molecule-1 (ICAM-1), and leukocyte function-associated antigen-3 (LFA-3).
|
Bacillus Calmette-Guerin (BCG) Alone
n=16 Participants
Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks
TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis
|
Total
n=32 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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Continuous
|
70.73 years
STANDARD_DEVIATION 11.21 • n=5 Participants
|
72.66 years
STANDARD_DEVIATION 9.61 • n=7 Participants
|
71.7 years
STANDARD_DEVIATION 10.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 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
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Enrollment Disease Status
CIS
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Enrollment Disease Status
Ta + CIS
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Enrollment Disease Status
T1 + CIS
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Enrollment Disease Status
Ta
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Enrollment Disease Status
T1
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Enrollment Disease Status
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Number of Patients with≥2 Prior Bacillus Calmette-Guerin (BCG) Induction Before Treatment
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed from start of therapy to 6 and 12 months following therapyPopulation: One patient withdrew consent after the first dose of drug in the BCG + PANVAC group. One patient withdrew consent prior to treatment in the BCG Alone group.
RFS is defined as the time from the start of intravesical Bacillus Calmette-Guerin (TICE BCG) therapy (week 3) until disease recurrence or death due to any cause in each arm. Recurrence is suspected and/or determined by urine cytology and/or cystoscopic exam and then confirmed pathologically after a transurethral resection of bladder tumor (TURBT). Positive cytology in the absence of pathologic confirmation is not considered to be a recurrence.
Outcome measures
| Measure |
Bacillus Calmette-Guerin (BCG) + PANVAC
n=15 Participants
Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks. PANVAC-V 2 x 10\^8 pfu subcutaneous (SQ) at week 0 only; PANVAC-F 1 x 10\^9 pfu SQ at weeks 3, 7, 11, and 15
TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis
PANVAC:A recombinant virus vector vaccine containing genes for human carcinoembryonic antigen (CEA), mucin-1 (MUC-1) and three co-stimulatory molecules (designated Triad of costimulatory molecules (TRICOM): B7.1, intercellular adhesion molecule-1 (ICAM-1), and leukocyte function-associated antigen-3 (LFA-3).
|
Bacillus Calmette-Guerin (BCG) Alone
n=15 Participants
Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks
TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis
|
|---|---|---|
|
Percentage of Participants Without Recurrence (Recurrence-free Survival (RFS)) With Bacillus Calmette-Guerin (BCG) + PANVAC Compared With BCG Alone at 6 and 12 Months
6 months
|
66 percentage of participants
Interval 46.6 to 95.3
|
60 percentage of participants
Interval 39.5 to 90.7
|
|
Percentage of Participants Without Recurrence (Recurrence-free Survival (RFS)) With Bacillus Calmette-Guerin (BCG) + PANVAC Compared With BCG Alone at 6 and 12 Months
12 months
|
44.4 percentage of participants
Interval 24.8 to 79.7
|
42.9 percentage of participants
Interval 22.9 to 80.0
|
SECONDARY outcome
Timeframe: Assessed from start of therapy to 6 and 12 months following therapyPopulation: One patient withdrew consent after the first dose of drug in the BCG + PANVAC group. One patient withdrew consent prior to treatment in the BCG Alone group.
PFS is the duration of time from start of TICE BCG therapy (week 3) to time of progression or death due to any cause in each study arm, whichever occurs first. Progression is defined as upstaging from a lower stage to a higher stage (e.g., Ta to T1 or T1 to T2-4; or any N+ or M+ in these high grade tumors.).TNM Classification in non-muscle invasive bladder cancer: Ta = Non-invasive papillary carcinoma; T1 = Tumor invades the subepithelial connective tissue; T2-4 = size of primary tumor; N+ or M+ = lymph node involvement and metastasis.
Outcome measures
| Measure |
Bacillus Calmette-Guerin (BCG) + PANVAC
n=15 Participants
Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks. PANVAC-V 2 x 10\^8 pfu subcutaneous (SQ) at week 0 only; PANVAC-F 1 x 10\^9 pfu SQ at weeks 3, 7, 11, and 15
TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis
PANVAC:A recombinant virus vector vaccine containing genes for human carcinoembryonic antigen (CEA), mucin-1 (MUC-1) and three co-stimulatory molecules (designated Triad of costimulatory molecules (TRICOM): B7.1, intercellular adhesion molecule-1 (ICAM-1), and leukocyte function-associated antigen-3 (LFA-3).
|
Bacillus Calmette-Guerin (BCG) Alone
n=15 Participants
Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks
TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis
|
|---|---|---|
|
Percentage of Participants Without Progression (Progression-Free Survival (PFS)) at 6 and 12 Months
6 months
|
79 percentage of participants
Interval 59.8 to 100.0
|
93 percentage of participants
Interval 80.3 to 100.0
|
|
Percentage of Participants Without Progression (Progression-Free Survival (PFS)) at 6 and 12 Months
12 months
|
78.5 percentage of participants
Interval 59.8 to 100.0
|
79.6 percentage of participants
Interval 56.9 to 100.0
|
SECONDARY outcome
Timeframe: Week 3 until recurrence or 12 months (whichever occurred first)Population: One patient withdrew consent after the first dose of drug in the BCG + PANVAC group. One patient withdrew consent prior to treatment in the BCG Alone group.
TTR is the duration of time measured from the start of TICE BCG therapy (week 3) until recurrence is noted. Recurrence is suspected and/or determined by urine cytology and/or cystoscopic exam and then confirmed pathologically after a TURBT. Positive cytology in the absence of pathologic confirmation is not considered to be a recurrence.
Outcome measures
| Measure |
Bacillus Calmette-Guerin (BCG) + PANVAC
n=15 Participants
Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks. PANVAC-V 2 x 10\^8 pfu subcutaneous (SQ) at week 0 only; PANVAC-F 1 x 10\^9 pfu SQ at weeks 3, 7, 11, and 15
TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis
PANVAC:A recombinant virus vector vaccine containing genes for human carcinoembryonic antigen (CEA), mucin-1 (MUC-1) and three co-stimulatory molecules (designated Triad of costimulatory molecules (TRICOM): B7.1, intercellular adhesion molecule-1 (ICAM-1), and leukocyte function-associated antigen-3 (LFA-3).
|
Bacillus Calmette-Guerin (BCG) Alone
n=15 Participants
Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks
TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis
|
|---|---|---|
|
Time to Recurrence
|
9.9 Months
Interval 3.7 to
The calculation of the confidence intervals is based on the number of occurrences (events). The upper limit of confidence interval cannot be calculated. This is probably due to the small sample size and number of events in each arm.
|
11.7 Months
Interval 4.0 to
The calculation of the confidence intervals is based on the number of occurrences (events). The upper limit of confidence interval cannot be calculated. This is probably due to the small sample size and number of events in each arm.
|
SECONDARY outcome
Timeframe: Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC Arm/Group, and 43 months and 12 days for BCG Alone Arm/Group.Population: One patient withdrew consent prior to treatment in the BCG Alone group.
Serious and non-serious adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Bacillus Calmette-Guerin (BCG) + PANVAC
n=16 Participants
Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks. PANVAC-V 2 x 10\^8 pfu subcutaneous (SQ) at week 0 only; PANVAC-F 1 x 10\^9 pfu SQ at weeks 3, 7, 11, and 15
TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis
PANVAC:A recombinant virus vector vaccine containing genes for human carcinoembryonic antigen (CEA), mucin-1 (MUC-1) and three co-stimulatory molecules (designated Triad of costimulatory molecules (TRICOM): B7.1, intercellular adhesion molecule-1 (ICAM-1), and leukocyte function-associated antigen-3 (LFA-3).
|
Bacillus Calmette-Guerin (BCG) Alone
n=15 Participants
Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks
TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis
|
|---|---|---|
|
Number of Participants With Serious and Non-Serious Adverse Events
|
16 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: up to 50 monthsPopulation: One patient withdrew consent after the first dose of drug in the BCG + PANVAC group. One patient withdrew consent prior to treatment in the BCG Alone group.
OS is defined as the time from treatment start date until date of death or date last known alive.
Outcome measures
| Measure |
Bacillus Calmette-Guerin (BCG) + PANVAC
n=15 Participants
Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks. PANVAC-V 2 x 10\^8 pfu subcutaneous (SQ) at week 0 only; PANVAC-F 1 x 10\^9 pfu SQ at weeks 3, 7, 11, and 15
TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis
PANVAC:A recombinant virus vector vaccine containing genes for human carcinoembryonic antigen (CEA), mucin-1 (MUC-1) and three co-stimulatory molecules (designated Triad of costimulatory molecules (TRICOM): B7.1, intercellular adhesion molecule-1 (ICAM-1), and leukocyte function-associated antigen-3 (LFA-3).
|
Bacillus Calmette-Guerin (BCG) Alone
n=15 Participants
Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks
TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis
|
|---|---|---|
|
Overall Survival (OS)
|
41.4 Months
Interval 22.6 to
Due to few deaths the upper 95% confidence limit is not reached for the BCG+PANVAC arm.
|
35.1 Months
Interval 0.0 to
Due to few deaths the upper 95% confidence limit is not reached for the BCG alone arm.
|
Adverse Events
BCG + PANVAC
Serious events: 3 serious events
Other events: 15 other events
Deaths: 3 deaths
BCG Alone
Serious events: 3 serious events
Other events: 13 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
BCG + PANVAC
n=15 participants at risk
Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks. PANVAC-V 2 x 10\^8 pfu subcutaneous (SQ) at week 0 only; PANVAC-F 1 x 10\^9 pfu SQ at weeks 3, 7, 11, and 15
TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis
PANVAC: A recombinant virus vector vaccine containing genes for human carcinoembryonic antigen (CEA), mucin-1 (MUC-1) and three co-stimulatory molecules (designated Triad of costimulatory molecules (TRICOM): B7.1, intercellular adhesion molecule-1 (ICAM-1), and leukocyte function-associated antigen-3 (LFA-3).
|
BCG Alone
n=15 participants at risk
Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks
TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis
|
|---|---|---|
|
Renal and urinary disorders
Hematuria
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Renal and urinary disorders
Urinary retention
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Infections and infestations
Bladder infection
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Infections and infestations
Lung infection
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
General disorders
Death, NOS
|
20.0%
3/15 • Number of events 3 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
13.3%
2/15 • Number of events 2 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
Other adverse events
| Measure |
BCG + PANVAC
n=15 participants at risk
Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks. PANVAC-V 2 x 10\^8 pfu subcutaneous (SQ) at week 0 only; PANVAC-F 1 x 10\^9 pfu SQ at weeks 3, 7, 11, and 15
TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis
PANVAC: A recombinant virus vector vaccine containing genes for human carcinoembryonic antigen (CEA), mucin-1 (MUC-1) and three co-stimulatory molecules (designated Triad of costimulatory molecules (TRICOM): B7.1, intercellular adhesion molecule-1 (ICAM-1), and leukocyte function-associated antigen-3 (LFA-3).
|
BCG Alone
n=15 participants at risk
Intravesical TICE BCG (50mg) once weekly starting in week 3 for a total of 6 weeks
TICE Bacillus Calmette-Guerin (BCG): TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Number of events 2 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Blood and lymphatic system disorders
Anemia
|
13.3%
2/15 • Number of events 3 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Cardiac disorders
Atrioventricular block first degree
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
General disorders
Chills
|
40.0%
6/15 • Number of events 7 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Cardiac disorders
Conduction disorder
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Investigations
Creatinine increased
|
13.3%
2/15 • Number of events 4 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
2/15 • Number of events 3 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
13.3%
2/15 • Number of events 3 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
General disorders
Edema limbs
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
General disorders
Fatigue
|
40.0%
6/15 • Number of events 9 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
33.3%
5/15 • Number of events 8 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
General disorders
Fever
|
26.7%
4/15 • Number of events 5 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
General disorders
Flu like symptoms
|
20.0%
3/15 • Number of events 9 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Renal and urinary disorders
Hematuria
|
33.3%
5/15 • Number of events 12 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
33.3%
5/15 • Number of events 8 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.7%
1/15 • Number of events 2 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 2 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Vascular disorders
Hypertension
|
13.3%
2/15 • Number of events 2 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Number of events 2 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
General disorders
Injection site reaction
|
80.0%
12/15 • Number of events 20 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Investigations
Lymphocyte count decreased
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
General disorders
Malaise
|
13.3%
2/15 • Number of events 3 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Infections and infestations
Nail infection
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 2 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
General disorders
Pain
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.3%
2/15 • Number of events 2 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Renal and urinary disorders
Proteinuria
|
26.7%
4/15 • Number of events 9 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
20.0%
3/15 • Number of events 7 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
3/15 • Number of events 3 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, 3+ Glucose in urine
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Cardiac disorders
Sinus bradycardia
|
20.0%
3/15 • Number of events 4 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Nervous system disorders
Sinus pain
|
6.7%
1/15 • Number of events 2 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
20.0%
3/15 • Number of events 5 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Cardiac disorders
Supraventricular tachycardia
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Gastrointestinal disorders
Toothache
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Renal and urinary disorders
Urinary frequency
|
13.3%
2/15 • Number of events 3 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
33.3%
5/15 • Number of events 13 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Renal and urinary disorders
Urinary incontinence
|
13.3%
2/15 • Number of events 2 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
13.3%
2/15 • Number of events 6 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Renal and urinary disorders
Urinary retention
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
20.0%
3/15 • Number of events 4 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Infections and infestations
Urinary tract infection
|
13.3%
2/15 • Number of events 3 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Renal and urinary disorders
Urinary tract pain
|
13.3%
2/15 • Number of events 6 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
33.3%
5/15 • Number of events 12 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Renal and urinary disorders
Urinary urgency
|
26.7%
4/15 • Number of events 4 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
20.0%
3/15 • Number of events 7 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Renal and urinary disorders
Urine discoloration
|
20.0%
3/15 • Number of events 3 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Infections and infestations
Bladder infection
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Renal and urinary disorders
Bladder spasm
|
13.3%
2/15 • Number of events 2 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
20.0%
3/15 • Number of events 7 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 2 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Renal and urinary disorders
Cystitis noninfective
|
6.7%
1/15 • Number of events 2 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Cardiac disorders
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Eye disorders
Eye pain
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Eye disorders
Floaters
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, fecal urgency
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
26.7%
4/15 • Number of events 7 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
13.3%
2/15 • Number of events 2 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
General disorders
Localized edema
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/15 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
6.7%
1/15 • Number of events 1 • Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC, and 43 months and 12 days for BCG Alone.
One patient withdrew consent prior to treatment in BCG Alone group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place