Comparison · NCT00008385-sae
Arm II (Selenium) vs Arm I (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
Cite this record
ConductScience Library. Arm II (Selenium) vs Arm I (Placebo): serious adverse events. Trial comparisons, record NCT00008385-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00008385-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 | 0.015 | 0.0088 | 0.0255 | wilson | |
| Risk in group 2 | 0.0189 | 0.00996 | 0.0355 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00384 | -0.0216 | 0.00994 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.797 | 0.343 | 1.85 | log | |
| Odds ratio, group 1 over group 2 | 0.793 | 0.337 | 1.87 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm II (Selenium) than on Arm I (Placebo) | 260 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Arm II (Selenium) | Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.~selenium: Given orally | 13 | 865 | EG001 |
| Group 2 | Arm I (Placebo) | Participants receive an oral yeast placebo as in arm II. placebo: Given orally | 9 | 477 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- assessed starting month 3 and continuing every 6 months (1 cycle=6 months, 8 cycles in total) for the duration of the study and for 30 days after the end of treatment
Source ClinicalTrials.gov
Trial
- Title
- Selenium in Preventing Tumor Growth in Patients With Previously Resected Stage I Non-small Cell Lung Cancer
- NCT number
- NCT00008385
- Phases
- PHASE3
- Conditions
- Lung Cancer
- Interventions
- placebo, selenium
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Results first posted
- 2016-05-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00008385?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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