Comparison · NCT01314313-sae
PIIA: SAPIEN XT - 2 Year vs Control: SAVR - 2 Year: 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. PIIA: SAPIEN XT - 2 Year vs Control: SAVR - 2 Year: serious adverse events. Trial comparisons, record NCT01314313-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01314313-sae
On this page
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 | 0.684 | 0.654 | 0.712 | wilson | |
| Risk in group 2 | 0.718 | 0.688 | 0.746 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0342 | -0.075 | 0.00693 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.952 | 0.898 | 1.01 | log | |
| Odds ratio, group 1 over group 2 | 0.849 | 0.698 | 1.03 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on PIIA: SAPIEN XT - 2 Year than on Control: SAVR - 2 Year | 29.3 | 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 | PIIA: SAPIEN XT - 2 Year | Edwards SAPIEN XT Transcatheter Heart Valve (THV) | 666 | 974 | EG000 |
| Group 2 | Control: SAVR - 2 Year | Surgical Aortic Valve Replacement (SAVR)~NOTE: SAVR with surgical bioprosthetic heart valve is the control arm. | 672 | 936 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock.
Source ClinicalTrials.gov
Trial
- Title
- PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk
- NCT number
- NCT01314313
- Phases
- NA
- Conditions
- Symptomatic Severe Aortic Stenosis
- Interventions
- TAVR Implantation with SAPIEN XT, SAVR Implantation
- Lead sponsor
- Edwards Lifesciences
- Results first posted
- 2018-08-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01314313?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01314313-sae