Comparison · NCT00689390-6e3c81f4
Participants From Boceprevir Studies vs Participants From Narlaprevir Studies: Number of Participants With Serious Adverse Events (SAEs) Reported During the LTFU
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: Number of Participants With Serious Adverse Events (SAEs) Reported During the LTFU. Trial comparisons, record NCT00689390-6e3c81f4. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00689390-6e3c81f4
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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 treat, for one more participant with the outcome 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 | OG000 |
| 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 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Serious Adverse Events (SAEs) Reported During the LTFU
- Description
Long-term safety was assessed based on the SAEs reported during the LTFU period. An SAE was any adverse drug or biologic or device experience occurring at any dose that resulted in any of the following outcomes: death, life-threatening AE, persistent or significant disability/incapacity, required in-patient hospitalization or prolongs hospitalization, congenital anomaly or birth defect. Important medical events that did not result in any of these outcomes could still be considered SAEs if they jeopardized the participant and/or required medical/surgical intervention, based on appropriate medical judgment. Grade 4 laboratory abnormalities and out of normal range liver function tests that were not accompanied by clinical manifestations were NOT considered SAEs.
- Time frame
- From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years)
- Population
- All enrolled participants were included in safety analyses.
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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