Comparison · NCT01539226-sae
Dapivirine Vaginal Ring vs Placebo Vaginal Ring: 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. Dapivirine Vaginal Ring vs Placebo Vaginal Ring: serious adverse events. Trial comparisons, record NCT01539226-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01539226-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 | 0.0314 | 0.0232 | 0.0423 | wilson | |
| Risk in group 2 | 0.0138 | 0.00728 | 0.026 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0176 | 0.00289 | 0.0303 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.27 | 1.11 | 4.65 | log | |
| Odds ratio, group 1 over group 2 | 2.32 | 1.12 | 4.79 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Dapivirine Vaginal Ring than on Placebo Vaginal Ring | 56.9 | 33 | 346 | 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 | Dapivirine Vaginal Ring | Vaginal Ring containing 25mg of Dapivirine~Dapivirine Vaginal Ring, 25 mg: Dapivirine Vaginal Ring containing 25 mg of dapivirine | 41 | 1,306 | EG001 |
| Group 2 | Placebo Vaginal Ring | Vaginal Ring containing 0.0 mg Dapivirine~Placebo Vaginal Ring: Dapivirine Vaginal Ring containing 0.0 mg of dapivirine | 9 | 652 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women
- NCT number
- NCT01539226
- Phases
- NA
- Conditions
- HIV Infections
- Interventions
- Placebo Vaginal Ring, Dapivirine Vaginal Ring, 25 mg
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Results first posted
- 2022-10-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01539226?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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