Comparison · NCT00458393-2d3f3a99
TDF/FTC vs Placebo: Grade 1 or Higher Creatinine Toxicity
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/FTC vs Placebo: Grade 1 or Higher Creatinine Toxicity. Trial comparisons, record NCT00458393-2d3f3a99. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00458393-2d3f3a99
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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 | 0.0263 | 0.0187 | 0.0369 | wilson | |
| Risk in group 2 | 0.0197 | 0.0133 | 0.0292 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0066 | -0.00554 | 0.019 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.33 | 0.791 | 2.25 | log | |
| Odds ratio, group 1 over group 2 | 1.34 | 0.787 | 2.29 | log | |
| Number needed to treat, for one more participant with the outcome on TDF/FTC than on Placebo | 152 | 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 | TDF/FTC | Daily oral emtricitabine/tenofovir disoproxil fumarate | 32 | 1,216 | OG000 |
| Group 2 | Placebo | Daily oral placebo | 24 | 1,217 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Grade 1 or Higher Creatinine Toxicity
- Description
Creatinine which reach grade 1 (mild, 1.1 to 1.3 local upper limit of normal) or higher by the US Division of AIDS grading table (version 1) or a 50% increase in creatinine from the baseline value. The DAIDS table can be found at https://rsc.tech-res.com/docs/default-source/safety/table\_for\_grading\_severity\_of\_adult\_pediatric\_adverse\_events.pdf
- Time frame
- Duration of follow-up, median 1.2 years
- Population
- All randomized participants which at least 1 follow-up creatinine value
Source ClinicalTrials.gov
Trial
- Title
- Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men
- NCT number
- NCT00458393
- Phases
- PHASE3
- Conditions
- HIV Infections
- Interventions
- daily TDF/FTC, Placebo
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Results first posted
- 2018-01-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00458393?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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