Comparison · NCT01384734-sae
FTR/RAL/TDF Total vs ATV/r/RAL/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. FTR/RAL/TDF Total vs ATV/r/RAL/TDF: serious adverse events. Trial comparisons, record NCT01384734-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01384734-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 | 0.175 | 0.129 | 0.234 | wilson | |
| Risk in group 2 | 0.157 | 0.0817 | 0.28 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0181 | -0.114 | 0.113 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.12 | 0.552 | 2.26 | log | |
| Odds ratio, group 1 over group 2 | 1.14 | 0.493 | 2.64 | log | |
| Number needed to harm, for one more participant with a serious adverse event on FTR/RAL/TDF Total than on ATV/r/RAL/TDF | 55.1 | 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 | FTR/RAL/TDF Total | All participants who were randomized to receive either of FTR 400mg BID, 800 mg BID, 600mg QD or 1200 mg QD (double-blind) along with 400 mg RAL BID (open label) and 300 mg TDF QD (open label). | 35 | 200 | EG000 |
| Group 2 | ATV/r/RAL/TDF | Participants were randomized to Reference group (open label) and administered ATV/r 300/100 mg once daily along with 400 mg RAL BID and 300 mg TDF QD. | 8 | 51 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment (Day 1) until 2117 days
Source ClinicalTrials.gov
Trial
- Title
- HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections
- NCT number
- NCT01384734
- Phases
- PHASE2
- Conditions
- Infection, Human Immunodeficiency Virus
- Interventions
- BMS-663068 400 mg, BMS-663068 800 mg, BMS-663068 600 mg, BMS-663068 1200 mg, Raltegravir 400 mg, Tenofovir 300 mg, Ritonavir 100 mg, Atazanavir 300 mg
- Lead sponsor
- ViiV Healthcare
- Results first posted
- 2018-11-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01384734?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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