Comparison · NCT02609386-deaths
Regimen 1 vs Regimen 2: deaths from any cause
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. Regimen 1 vs Regimen 2: deaths from any cause. Trial comparisons, record NCT02609386-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02609386-deaths
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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 | 0.271 | 0.181 | 0.385 | wilson | |
| Risk in group 2 | 0.314 | 0.186 | 0.48 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0429 | -0.231 | 0.129 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.864 | 0.464 | 1.61 | log | |
| Odds ratio, group 1 over group 2 | 0.813 | 0.335 | 1.97 | log | |
| Number needed to treat, for one fewer death from any cause on Regimen 1 than on Regimen 2 | 23.3 | 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 | Regimen 1 | IRX Regimen with IRX-2, cyclophosphamide, indomethacin, zinc-containing multivitamins, and omeprazole as neoadjuvant and adjuvant therapy.~IRX-2: Method of Administration: Administered for 10 days as subcutaneous bilateral injections in the upper neck.~Cyclophosphamide: Method of Administration: Cyclophosphamide is administered once by IV.~Indomethacin: Method of Administration: Indomethacin is administered orally for 21 days.~Zinc-containing multivitamins: Method of Administration: Zinc-containing multivitamins are administered orally for 21 days.~Omeprazole: Method of Administration: Omeprazole is administered orally for 21 days. | 19 | 70 | EG000 |
| Group 2 | Regimen 2 | Regimen 1 but without IRX-2~Cyclophosphamide: Method of Administration: Cyclophosphamide is administered once by IV.~Indomethacin: Method of Administration: Indomethacin is administered orally for 21 days.~Zinc-containing multivitamins: Method of Administration: Zinc-containing multivitamins are administered orally for 21 days.~Omeprazole: Method of Administration: Omeprazole is administered orally for 21 days. | 11 | 35 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
AEs/SAEs were collected over a period of approximately 60 days (i.e., from the day of randomization through 30 days after the last dose of study drug). If booster treatments were administered, AEs/SAEs were collected through 30 days after the last dose of study drug. AE data were collected over a period of approximately 2 years and 10 months. All cause mortality was assessed through study completion, approximately 76 months.
Source ClinicalTrials.gov
Trial
- Title
- IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity
- NCT number
- NCT02609386
- Phases
- PHASE2
- Conditions
- Squamous Cell Carcinoma of the Oral Cavity
- Interventions
- IRX-2, Cyclophosphamide, Indomethacin, Zinc-containing multivitamin, Omeprazole
- Lead sponsor
- Brooklyn ImmunoTherapeutics, LLC
- Results first posted
- 2024-01-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02609386?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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