Comparison · NCT01667081-0c898802
GZR 100 mg + EBR 50 mg +/- RBV vs Other GZR Regimen: Number of Participants Who Experienced a Drug-Related Serious Adverse Event (SAE) During the Long-Term Follow-Up
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. GZR 100 mg + EBR 50 mg +/- RBV vs Other GZR Regimen: Number of Participants Who Experienced a Drug-Related Serious Adverse Event (SAE) During the Long-Term Follow-Up. Trial comparisons, record NCT01667081-0c898802. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01667081-0c898802
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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 | 0.000524 | 0.0000925 | 0.00296 | wilson | |
| Risk in group 2 | 0.0019 | 0.000336 | 0.0107 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00138 | -0.0102 | 0.00152 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.276 | 0.0173 | 4.4 | log | |
| Odds ratio, group 1 over group 2 | 0.275 | 0.0172 | 4.41 | log | |
| Number needed to treat, for one fewer participant with the outcome on GZR 100 mg + EBR 50 mg +/- RBV than on Other GZR Regimen | 726 | 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 | GZR 100 mg + EBR 50 mg +/- RBV | Participants previously received GZR 100mg +EBR 50mg with or without RBV in a prior study. | 1 | 1,909 | OG000 |
| Group 2 | Other GZR Regimen | Participants previously received at least one dose of GZR in a prior study | 1 | 526 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Who Experienced a Drug-Related Serious Adverse Event (SAE) During the Long-Term Follow-Up
- Description
A serious adverse event (SAE) is any adverse experience occurring at any dose that either results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose (whether accidental or intentional), or other important medical events that may not result in death, not be life threatening, or not require hospitalization may be considered a serious adverse experience when, based upon appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed previously. The study investigator determined whether the adverse event was drug-related.
- Time frame
- Up to ~60 months after enrollment in this study
- Population
All participants treated with GZR in a prior study. Three participants were excluded from analysis; two participants enrolled in error failed to receive at least one dose of GZR in a prior study (each received a comparator regimen in a prior base study) and one participant had insufficient long-term follow-up data (participant withdrew consent on Day 27).
Source ClinicalTrials.gov
Trial
- Title
- Durability of Virologic Response and/or Viral Resistance Patterns in Participants With Chronic Hepatitis C Who Have Been Previously Treated With Grazoprevir (MK-5172) (MK-5172-017)
- NCT number
- NCT01667081
- Phases
- Conditions
- Hepatitis C
- Interventions
- Grazoprevir
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2022-06-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01667081?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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