Comparison · NCT01485991-sae
Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin vs Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin: 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. Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin vs Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin: serious adverse events. Trial comparisons, record NCT01485991-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01485991-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 | 0.058 | 0.0386 | 0.0863 | wilson | |
| Risk in group 2 | 0.141 | 0.109 | 0.179 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0826 | -0.126 | -0.0405 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.413 | 0.257 | 0.664 | log | |
| Odds ratio, group 1 over group 2 | 0.377 | 0.224 | 0.632 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin than on Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 12.1 | 7.97 | 24.7 | 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 | Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks. | 22 | 379 | EG000 |
| Group 2 | Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin | 2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks. | 54 | 384 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline up to Follow-up (Week 72)
Source ClinicalTrials.gov
Trial
- Title
TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy
- NCT number
- NCT01485991
- Phases
- PHASE3
- Conditions
- Hepatitis C
- Interventions
- TMC435, TVR
- Lead sponsor
- Janssen R&D Ireland
- Results first posted
- 2015-04-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01485991?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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