Comparison · NCT00448669-sae
TDF-FTC, Condoms, Risk Counseling vs Placebo, Condoms, Risk Counseling: 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-FTC, Condoms, Risk Counseling vs Placebo, Condoms, Risk Counseling: serious adverse events. Trial comparisons, record NCT00448669-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00448669-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 | 0.0687 | 0.0513 | 0.0916 | wilson | |
| Risk in group 2 | 0.0724 | 0.0543 | 0.0958 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00363 | -0.0328 | 0.0255 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.95 | 0.632 | 1.43 | log | |
| Odds ratio, group 1 over group 2 | 0.946 | 0.61 | 1.47 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on TDF-FTC, Condoms, Risk Counseling than on Placebo, Condoms, Risk Counseling | 276 | 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, Condoms, Risk Counseling | Participants randomized to the active arm received daily oral TDF-FTC along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events.~Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg: Daily oral single dose pill containing 300 mg TDF and 200 mg FTC. | 42 | 611 | EG000 |
| Group 2 | Placebo, Condoms, Risk Counseling | Participants randomized to the placebo arm received a daily oral placebo tablet along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events.~TDF-FTC placebo: Placebo comparator for TDF-FTC | 44 | 608 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years.
Source ClinicalTrials.gov
Trial
- Title
- Botswana TDF/FTC Oral HIV Prophylaxis Trial
- NCT number
- NCT00448669
- Phases
- PHASE2, PHASE3
- Conditions
- HIV Infections
- Interventions
- Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg, Placebo Oral Tablet
- Lead sponsor
- Centers for Disease Control and Prevention
- Results first posted
- 2020-02-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00448669?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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