Comparison · NCT01437605-sae
A: recMAGE-A3 + AS15 vs B: recMAGE-A3 + AS15 + Poly IC:LC: 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. A: recMAGE-A3 + AS15 vs B: recMAGE-A3 + AS15 + Poly IC:LC: serious adverse events. Trial comparisons, record NCT01437605-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01437605-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 | 0.333 | 0.121 | 0.646 | wilson | |
| Risk in group 2 | 0.2 | 0.0362 | 0.624 | wilson | |
| Risk difference, group 1 minus group 2 | 0.133 | -0.341 | 0.486 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.67 | 0.23 | 12.1 | log | |
| Odds ratio, group 1 over group 2 | 2 | 0.15 | 26.7 | log | |
| Number needed to harm, for one more participant with a serious adverse event on A: recMAGE-A3 + AS15 than on B: recMAGE-A3 + AS15 + Poly IC:LC | 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 | A: recMAGE-A3 + AS15 | ASCI injections without Poly IC:LC~MAGE-A3 ASCI injections without Poly IC:LC: MAGE-A3 ASCI injections without Poly IC:LC as outlined in Detailed Description | 3 | 9 | EG000 |
| Group 2 | B: recMAGE-A3 + AS15 + Poly IC:LC | ASCI injections with Poly IC:LC~MAGE-A3 ASCI injections with Poly IC:LC: MAGE-A3 ASCI injections with Poly IC:LC as outlined in Detailed Description | 1 | 5 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 6 years and 11 months
Source ClinicalTrials.gov
Trial
- Title
- Phase II Study to Assess the Safety and Immunogenicity of recMAGE-A3+AS15 ASCI With or Without Poly IC:LC
- NCT number
- NCT01437605
- Phases
- PHASE2
- Conditions
- Melanoma
- Interventions
- MAGE-A3 ASCI injections without Poly IC:LC, MAGE-A3 ASCI injections with Poly IC:LC
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Results first posted
- 2019-12-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01437605?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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