Comparison · NCT01341652-sae
GM-CSF Alone vs pTVG-HP Vaccine With GM-CSF: serious adverse events
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. GM-CSF Alone vs pTVG-HP Vaccine With GM-CSF: serious adverse events. Trial comparisons, record NCT01341652-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01341652-sae
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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 | 0.122 | 0.0573 | 0.242 | wilson | |
| Risk in group 2 | 0.06 | 0.0206 | 0.162 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0624 | -0.0587 | 0.189 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.04 | 0.54 | 7.71 | log | |
| Odds ratio, group 1 over group 2 | 2.19 | 0.515 | 9.28 | log | |
| Number needed to harm, for one more participant with a serious adverse event on GM-CSF Alone than on pTVG-HP Vaccine With GM-CSF | 16 | 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 | GM-CSF Alone | rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period~rhGM-CSF: rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period | 6 | 49 | EG000 |
| Group 2 | pTVG-HP Vaccine With GM-CSF | pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period~pTVG-HP: pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period | 3 | 50 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- up to 2 years
Source ClinicalTrials.gov
Trial
- Title
- Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer
- NCT number
- NCT01341652
- Phases
- PHASE2
- Conditions
- Prostate Cancer
- Interventions
- pTVG-HP, rhGM-CSF
- Lead sponsor
- University of Wisconsin, Madison
- Results first posted
- 2020-11-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01341652?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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