Comparison · NCT00982397-sae
DR-ICD/CRT-D vs VR-ICD: 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. DR-ICD/CRT-D vs VR-ICD: serious adverse events. Trial comparisons, record NCT00982397-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00982397-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 | 0.224 | 0.206 | 0.243 | wilson | |
| Risk in group 2 | 0.166 | 0.142 | 0.195 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0574 | 0.0241 | 0.0886 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.35 | 1.12 | 1.61 | log | |
| Odds ratio, group 1 over group 2 | 1.44 | 1.16 | 1.8 | log | |
| Number needed to harm, for one more participant with a serious adverse event on DR-ICD/CRT-D than on VR-ICD | 17.4 | 11.3 | 41.6 | 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 | DR-ICD/CRT-D | Patients implanted with a dual-chamber ICD (DR-ICD) or cardiac resynchronization therapy defibrillator (CRT-D). | 452 | 2,019 | EG000 |
| Group 2 | VR-ICD | Patients implanted with a single-chamber ICD (VR-ICD). | 125 | 751 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Reported Serious Adverse Events (SAEs) include events starting on or after the date of consent and through study completion, an average of 22 months.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Clinical Performance of the Protecta ICD and CRT-D
- NCT number
- NCT00982397
- Phases
- NA
- Conditions
- Tachyarrhythmias, Heart Failure, Ventricular Dysfunction
- Interventions
- Protecta VR-ICD, Protecta DR-ICD or CRT-D
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Results first posted
- 2017-11-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00982397?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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