Comparison · NCT01480284-sae
TDF 300 mg OD vs ETV 0.5 mg OD: 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. TDF 300 mg OD vs ETV 0.5 mg OD: serious adverse events. Trial comparisons, record NCT01480284-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01480284-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 | 0.0642 | 0.0315 | 0.127 | wilson | |
| Risk in group 2 | 0.0357 | 0.00985 | 0.121 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0285 | -0.063 | 0.0961 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.8 | 0.386 | 8.37 | log | |
| Odds ratio, group 1 over group 2 | 1.85 | 0.372 | 9.23 | log | |
| Number needed to harm, for one more participant with a serious adverse event on TDF 300 mg OD than on ETV 0.5 mg OD | 35.1 | 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 | TDF 300 mg OD | Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks. | 7 | 109 | EG000 |
| Group 2 | ETV 0.5 mg OD | Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks. | 2 | 56 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to average of 96 weeks).
Source ClinicalTrials.gov
Trial
- Title
- Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B Untreated With Nucleic Acid Analogue
- NCT number
- NCT01480284
- Phases
- PHASE3
- Conditions
- Hepatitis B, Chronic
- Interventions
- GSK548470 300 mg tablet, ETV 0.5 mg capsule
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2013-10-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01480284?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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