Comparison · NCT01259856-sae
PEGASYS vs Hydroxyurea: 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. PEGASYS vs Hydroxyurea: serious adverse events. Trial comparisons, record NCT01259856-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01259856-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 | 0.171 | 0.105 | 0.266 | wilson | |
| Risk in group 2 | 0.0465 | 0.0182 | 0.114 | wilson | |
| Risk difference, group 1 minus group 2 | 0.124 | 0.03 | 0.224 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.67 | 1.26 | 10.7 | log | |
| Odds ratio, group 1 over group 2 | 4.22 | 1.33 | 13.4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on PEGASYS than on Hydroxyurea | 8.05 | 4.46 | 33.4 | 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 | PEGASYS | The subject received the PEGASYS at a dose level of 45 micrograms weekly and gradually increased to the maximum dose of 180 micrograms per week. The dose was administered by prefilled syringes and injected subcutaneously. Subjects received therapy for up to 12 months.~Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment. | 14 | 82 | EG000 |
| Group 2 | Hydroxyurea | Subjects received a 500mg tablet to be taken twice daily for up to 12 months of treatment.~Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment. | 4 | 86 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 4 years
Source ClinicalTrials.gov
Trial
- Title
- Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea in Polycythemia Vera (PV) and Essential Thrombocythemia (ET)
- NCT number
- NCT01259856
- Phases
- PHASE3
- Conditions
- High Risk Polycythemia Vera, High Risk Essential Thrombocythemia
- Interventions
- PEGASYS, Hydroxyurea, Aspirin
- Lead sponsor
- Ronald Hoffman
- Results first posted
- 2018-07-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01259856?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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