Comparison · NCT02015104-31be93be
Bacillus Calmette-Guerin (BCG) + PANVAC vs Bacillus Calmette-Guerin (BCG) Alone: Number of Participants With Serious and Non-Serious Adverse Events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Bacillus Calmette-Guerin (BCG) + PANVAC vs Bacillus Calmette-Guerin (BCG) Alone: Number of Participants With Serious and Non-Serious Adverse Events. Trial comparisons, record NCT02015104-31be93be. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02015104-31be93be
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 1 | 0.806 | 1 | wilson | |
| Risk in group 2 | 0.867 | 0.621 | 0.963 | wilson | |
| Risk difference, group 1 minus group 2 | 0.133 | -0.0828 | 0.379 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.15 | 0.946 | 1.41 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Bacillus Calmette-Guerin (BCG) + PANVAC than on Bacillus Calmette-Guerin (BCG) Alone | 7.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 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). | 16 | 16 | OG000 |
| Group 2 | 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 | 13 | 15 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Serious and Non-Serious Adverse Events
- Description
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.
- Time frame
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.
Source ClinicalTrials.gov
Trial
- Title
- 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 number
- NCT02015104
- Phases
- PHASE2
- Conditions
- Bladder Cancer
- Interventions
- BCG intravesical live (TICE Bacillus Calmette-Guerin (BCG)), PANVAC
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2020-01-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02015104?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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