Comparison · NCT00689390-sae
Participants From Boceprevir Studies vs Participants From Narlaprevir Studies: 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. Participants From Boceprevir Studies vs Participants From Narlaprevir Studies: serious adverse events. Trial comparisons, record NCT00689390-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00689390-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 | 0.0713 | 0.0606 | 0.0837 | wilson | |
| Risk in group 2 | 0.0426 | 0.0117 | 0.142 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0288 | -0.0717 | 0.062 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.68 | 0.428 | 6.57 | log | |
| Odds ratio, group 1 over group 2 | 1.73 | 0.415 | 7.2 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Participants From Boceprevir Studies than on Participants From Narlaprevir Studies | 34.8 | 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 | Participants From Boceprevir Studies | Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study. | 136 | 1,907 | EG000 |
| Group 2 | Participants From Narlaprevir Studies | Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study. | 2 | 47 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years)
Source ClinicalTrials.gov
Trial
- Title
- Three-year Follow-up of Participants After Administration of Boceprevir or Narlaprevir for the Treatment of Chronic Hepatitis C (P05063)
- NCT number
- NCT00689390
- Phases
- PHASE2, PHASE3
- Conditions
- Hepatitis C, Chronic, Hepacivirus
- Interventions
- Boceprevir, Narlaprevir, Peginterferon alfa-2b, Ribavirin, Blood/Plasma Collection
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2015-10-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00689390?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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