Comparison · NCT04925752-sae
Randomized Blinded Phase: LEN + Placebo-to-match (PTM) F/TDF vs Randomized Blinded Phase: Placebo LEN + F/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
Cite this record
ConductScience Library. Randomized Blinded Phase: LEN + Placebo-to-match (PTM) F/TDF vs Randomized Blinded Phase: Placebo LEN + F/TDF: serious adverse events. Trial comparisons, record NCT04925752-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04925752-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 | 0.0325 | 0.0259 | 0.0408 | wilson | |
| Risk in group 2 | 0.0395 | 0.0295 | 0.0528 | wilson | |
| Risk difference, group 1 minus group 2 | -0.007 | -0.0219 | 0.00604 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.823 | 0.567 | 1.19 | log | |
| Odds ratio, group 1 over group 2 | 0.817 | 0.555 | 1.2 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Randomized Blinded Phase: LEN + Placebo-to-match (PTM) F/TDF than on Randomized Blinded Phase: Placebo LEN + F/TDF | 143 | 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 | Randomized Blinded Phase: LEN + Placebo-to-match (PTM) F/TDF | Participants received lenacapavir (LEN) 927 mg subcutaneous (SC) injection, every 26 weeks, starting on Day 1 up to for approximately 52 weeks. Participants also received loading dose of LEN 600 mg tablet orally, once daily on Day 1 and Day 2. Participants received placebo to match (PTM) emtricitabine/tenofovir disoproxil fumarate (F/TDF) tablet orally, once daily, up to approximately 52 weeks. | 71 | 2,183 | EG000 |
| Group 2 | Randomized Blinded Phase: Placebo LEN + F/TDF | Participants received F/TDF tablet on Day 1 orally, once daily up to for approximately 52 weeks. Participants also received PTM LEN SC injection every 26 weeks starting on Day 1 up to approximately 52 weeks and PTM LEN tablet, orally, once daily on Day 1 and Day 2. | 43 | 1,088 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All-Cause Mortality and Adverse Events: Up to 149 weeks
Source ClinicalTrials.gov
Trial
- Title
- Pre-Exposure Prophylaxis Study of Lenacapavir in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People at Risk for HIV Infection
- NCT number
- NCT04925752
- Phases
- PHASE3
- Conditions
- Pre-Exposure Prophylaxis of HIV Infection
- Interventions
- Oral Lenacapavir (LEN), F/TDF, Sub-cutaneous (SC) Lenacapavir (LEN), Placebo SC LEN, PTM F/TDF, PTM Oral LEN, F/TAF (for US participants only)
- Lead sponsor
- Gilead Sciences
- Results first posted
- 2025-09-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04925752?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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