Comparison · NCT02117024-sae
Viagenpumatucel-L Plus Metronomic Cyclophosphamide vs Chemotherapy Alone: 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. Viagenpumatucel-L Plus Metronomic Cyclophosphamide vs Chemotherapy Alone: serious adverse events. Trial comparisons, record NCT02117024-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02117024-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 | 0.395 | 0.264 | 0.544 | wilson | |
| Risk in group 2 | 0.4 | 0.219 | 0.613 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00465 | -0.255 | 0.23 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.988 | 0.515 | 1.9 | log | |
| Odds ratio, group 1 over group 2 | 0.981 | 0.332 | 2.9 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Viagenpumatucel-L Plus Metronomic Cyclophosphamide than on Chemotherapy Alone | 215 | 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 | Viagenpumatucel-L Plus Metronomic Cyclophosphamide | Viagenpumatucel-L (HS-110) given as 1\*10\^7 cells for 12 weekly injections followed by injections every 9 weeks for up to 12 months or until discontinuation from study treatment, whichever occurs first, plus metronomic cyclophosphamide therapy for the first 12 weeks.~Viagenpumatucel-L: Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig~Metronomic Cyclophosphamide: One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks | 17 | 43 | EG000 |
| Group 2 | Chemotherapy Alone | Patients will be treated with a physician's choice regimen until progression.~Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed): Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice:~* Vinorelbine~* Erlotinib~* Gemcitabine~* Paclitaxel~* Docetaxel~* Pemetrexed | 8 | 20 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 1 year and 5 months
Source ClinicalTrials.gov
Trial
- Title
- A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer
- NCT number
- NCT02117024
- Phases
- PHASE2
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Viagenpumatucel-L, Metronomic Cyclophosphamide, Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed)
- Lead sponsor
- Heat Biologics
- Results first posted
- 2020-02-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02117024?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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