Comparison · NCT01079806-sae
ETV (Entecavir) vs 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. ETV (Entecavir) vs PLACEBO: serious adverse events. Trial comparisons, record NCT01079806-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01079806-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 | 0.0333 | 0.013 | 0.0826 | wilson | |
| Risk in group 2 | 0.15 | 0.081 | 0.261 | wilson | |
| Risk difference, group 1 minus group 2 | -0.117 | -0.23 | -0.0319 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.222 | 0.0713 | 0.692 | log | |
| Odds ratio, group 1 over group 2 | 0.195 | 0.0575 | 0.664 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on ETV (Entecavir) than on PLACEBO | 8.57 | 4.35 | 31.4 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | ETV (Entecavir) | Subjects received 0.015 milligram per kilogram per day (mg/kg/day) (up to a maximum dose of 0.5 mg/day) ETV as oral solution or tablets, once daily (QD). | 4 | 120 | EG000 |
| Group 2 | PLACEBO | Subjects received ETV matched placebo as oral solution or tablets, QD. | 9 | 60 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All non-serious adverse events were collected from start of study treatment through Week 48, while all serious adverse events were evaluated through out the study (5 years).
Source ClinicalTrials.gov
Trial
- Title
- A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus Infection
- NCT number
- NCT01079806
- Phases
- PHASE3
- Conditions
- Chronic Hepatitis B Virus, Pediatric
- Interventions
- Entecavir, Placebo
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2014-04-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01079806?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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