Comparison · NCT00409188-sae
Tecemotide (L-BLP25) + Cyclophosphamide vs Saline + Placebo: 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. Tecemotide (L-BLP25) + Cyclophosphamide vs Saline + Placebo: serious adverse events. Trial comparisons, record NCT00409188-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00409188-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 | 0.296 | 0.269 | 0.325 | wilson | |
| Risk in group 2 | 0.317 | 0.276 | 0.36 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0207 | -0.0716 | 0.0287 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.935 | 0.795 | 1.1 | log | |
| Odds ratio, group 1 over group 2 | 0.907 | 0.717 | 1.15 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Tecemotide (L-BLP25) + Cyclophosphamide than on Saline + Placebo | 48.4 | 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 | Tecemotide (L-BLP25) + Cyclophosphamide | A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented. | 303 | 1,024 | EG000 |
| Group 2 | Saline + Placebo | A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented. | 151 | 477 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 66 months
Source ClinicalTrials.gov
Trial
- Title
- Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer (START)
- NCT number
- NCT00409188
- Phases
- PHASE3
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Tecemotide (L-BLP25), Single low dose cyclophosphamide, Placebo
- Lead sponsor
- EMD Serono
- Results first posted
- 2015-11-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00409188?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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GET https://conductscience.org/api/comparisons/v1/NCT00409188-sae