Comparison · NCT01617096-eaf5265f
Dapivirine Vaginal Ring vs Placebo Ring: The Number of Participants That Experienced Grade 2, 3, 4 and Serious Adverse Events Over the Investigational Product Used Period (25 mg Dapivirine Administered in a Silicone Elastomer Vaginal Matrix Ring (DVR), Inserted Once Every 4 Weeks).
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 Ring: The Number of Participants That Experienced Grade 2, 3, 4 and Serious Adverse Events Over the Investigational Product Used Period (25 mg Dapivirine Administered in a Silicone Elastomer Vaginal Matrix Ring (DVR), Inserted Once Every 4 Weeks). Trial comparisons, record NCT01617096-eaf5265f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01617096-eaf5265f
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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 | 0.942 | 0.928 | 0.954 | wilson | |
| Risk in group 2 | 0.935 | 0.921 | 0.947 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00671 | -0.0117 | 0.0252 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.988 | 1.03 | log | |
| Odds ratio, group 1 over group 2 | 1.12 | 0.817 | 1.55 | log | |
| Number needed to treat, for one more participant with the outcome on Dapivirine Vaginal Ring than on Placebo Ring | 149 | 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 | Dapivirine Vaginal Ring | Vaginal ring containing 25mg dapivirine~Dapivirine Vaginal Ring: Dosage form: vaginal ring Dosage: 25mg Frequency: monthly Duration: 12 months | 1,237 | 1,313 | OG000 |
| Group 2 | Placebo Ring | Vaginal ring containing no drug substance~Placebo Ring: Vaginal ring containing no drug substance | 1,231 | 1,316 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
The Number of Participants That Experienced Grade 2, 3, 4 and Serious Adverse Events Over the Investigational Product Used Period (25 mg Dapivirine Administered in a Silicone Elastomer Vaginal Matrix Ring (DVR), Inserted Once Every 4 Weeks).
- Description
Participants with grade 2 adverse events, judged to be related to investigational product, grade 3 and grade 4 adverse events and all serious adverse events.~DAIDS severity grades are defined as follows:~Grade 1 = mild Grade 2 = moderate Grade 3 = severe Grade 4 = potentially life-threatening Grade 5 = death
- Time frame
- minimum of 12 months and a maximum of 14 months per participant
- Population
The Primary Safety Cohort (or ITT Cohort) included all eligible, randomized participants. All participants were analyzed as members of the treatment group to which they were randomized regardless of adherence to the planned course of treatment.
Source ClinicalTrials.gov
Trial
- Title
- Phase 3 Safety and Effectiveness Trial of Dapivirine Vaginal Ring for Prevention of HIV-1 in Women
- NCT number
- NCT01617096
- Phases
- PHASE3
- Conditions
- HIV Infections
- Interventions
- Dapivirine Vaginal Ring, Placebo Ring
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Results first posted
- 2022-12-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01617096?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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