Comparison · NCT00849121-c99ffc2f
1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 vs 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12: The Number of Participants Who Are Metastasis-free at One Year.
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 vs 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12: The Number of Participants Who Are Metastasis-free at One Year. Trial comparisons, record NCT00849121-c99ffc2f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00849121-c99ffc2f
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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 | 0.75 | 0.409 | 0.929 | wilson | |
| Risk in group 2 | 0.667 | 0.354 | 0.879 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0833 | -0.318 | 0.443 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.13 | 0.611 | 2.07 | log | |
| Odds ratio, group 1 over group 2 | 1.5 | 0.181 | 12.5 | log | |
| Number needed to treat, for one more participant with the outcome on 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 than on 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | 12 | 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 | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression | 6 | 8 | OG000 |
| Group 2 | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response. | 6 | 9 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- The Number of Participants Who Are Metastasis-free at One Year.
- Description
The number of subjects who are metastatic-free at one year after starting study treatment will be tabulated for each arm. CT Scans and Bone Scans will be obtained at one year to determine whether metastatic disease is present.
- Time frame
- one year from study entry
- Population
Source ClinicalTrials.gov
Trial
- Title
- Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer
- NCT number
- NCT00849121
- Phases
- PHASE2
- Conditions
- Prostate Cancer
- Interventions
- pTVG-HP with rhGM-CSF, pTVG-HP with rhGM-CSF
- Lead sponsor
- University of Wisconsin, Madison
- Results first posted
- 2014-09-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00849121?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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