Comparison · NCT02536378-sae
PP (Per Protocol) vs ITT (Intention to Treat): 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. PP (Per Protocol) vs ITT (Intention to Treat): serious adverse events. Trial comparisons, record NCT02536378-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02536378-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 | 0.0427 | 0.0295 | 0.0614 | wilson | |
| Risk in group 2 | 0.0202 | 0.0121 | 0.0337 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0225 | 0.00365 | 0.0429 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.11 | 1.12 | 3.99 | log | |
| Odds ratio, group 1 over group 2 | 2.16 | 1.12 | 4.16 | log | |
| Number needed to harm, for one more participant with a serious adverse event on PP (Per Protocol) than on ITT (Intention to Treat) | 44.5 | 23.3 | 274 | from the risk difference interval |
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 | PP (Per Protocol) | Patients who underwent the study procedure, independent of the success of the procedure and in the absence of major protocol deviations. The analysis of the PP population excludes those subjects for whom a major protocol deviation was identified by the CEC | 27 | 632 | EG000 |
| Group 2 | ITT (Intention to Treat) | All patients who were enrolled in the pivotal phase of the study in which a major protocol deviation was identified by the CEC. | 14 | 692 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected throughout the life of the study: 3 years, 6 months
Source ClinicalTrials.gov
Trial
- Title
- POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE
- NCT number
- NCT02536378
- Phases
- Conditions
- Carotid Artery Disease
- Interventions
- Lead sponsor
- Silk Road Medical
- Results first posted
- 2020-07-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02536378?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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