Comparison · NCT01300234-sae
TDF-TDF vs ADV-TDF: 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. TDF-TDF vs ADV-TDF: serious adverse events. Trial comparisons, record NCT01300234-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01300234-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 | 0.0467 | 0.0269 | 0.0798 | wilson | |
| Risk in group 2 | 0.0794 | 0.052 | 0.119 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0327 | -0.0773 | 0.0103 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.588 | 0.294 | 1.18 | log | |
| Odds ratio, group 1 over group 2 | 0.568 | 0.272 | 1.19 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on TDF-TDF than on ADV-TDF | 30.6 | 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-TDF | In first double-blinded treatment period, participants self-administered TDF 300 mg tablets plus matching ADV placebo at the same time QD for 48 Weeks. In second open-label treatment period, participants self-administered TDF 300 mg QD for additional 192 Weeks. | 12 | 257 | EG000 |
| Group 2 | ADV-TDF | In first double-blinded treatment period, participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time QD for 48 Weeks. In second open-label treatment period, participants self-administered TDF 300 mg QD for additional 192 Weeks. | 20 | 252 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 240 weeks treatment period and 24 weeks follow-up visit off treatment.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) 300mg in Chinese Subjects With Chronic Hepatitis B (CHB)
- NCT number
- NCT01300234
- Phases
- PHASE3
- Conditions
- Hepatitis B
- Interventions
- Tenofovir disoproxil fumarate (TDF) tablets, Adefovir dipivoxil (ADV) tablets
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2013-08-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01300234?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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