Comparison · NCT00410072-sae
ETV 0.5 mg vs ETV/TDF 0.5 mg +TDF 300 mg: 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. ETV 0.5 mg vs ETV/TDF 0.5 mg +TDF 300 mg: serious adverse events. Trial comparisons, record NCT00410072-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00410072-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 | 0.0714 | 0.0422 | 0.118 | wilson | |
| Risk in group 2 | 0.0711 | 0.0428 | 0.116 | wilson | |
| Risk difference, group 1 minus group 2 | 0.000363 | -0.053 | 0.0551 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.486 | 2.08 | log | |
| Odds ratio, group 1 over group 2 | 1.01 | 0.459 | 2.2 | log | |
| Number needed to harm, for one more participant with a serious adverse event on ETV 0.5 mg than on ETV/TDF 0.5 mg +TDF 300 mg | 2,760 | 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 | ETV 0.5 mg | ETV 0.5 mg monotherapy given QD for 100 weeks | 13 | 182 | EG000 |
| Group 2 | ETV/TDF 0.5 mg +TDF 300 mg | ETV 0.5 mg plus TDF 300 mg combination therapy given once daily (QD) for 100 weeks | 14 | 197 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Week 0 to Week 100 (on study), Post-dosing follow-up - 24 Weeks
Source ClinicalTrials.gov
Trial
- Title
- Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B
- NCT number
- NCT00410072
- Phases
- PHASE3
- Conditions
- Hepatitis B, Chronic
- Interventions
- Entecavir, Entecavir + Tenofovir
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2012-02-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00410072?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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