Comparison · NCT03547154-sae
INTRON A, 5 MIU/m^2 Daily vs PEG-Intron, 6.0 mcg/kg Weekly: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. INTRON A, 5 MIU/m^2 Daily vs PEG-Intron, 6.0 mcg/kg Weekly: serious adverse events. Trial comparisons, record NCT03547154-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03547154-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 | 0.358 | 0.291 | 0.432 | wilson | |
| Risk in group 2 | 0.433 | 0.361 | 0.508 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0744 | -0.175 | 0.0287 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.828 | 0.637 | 1.08 | log | |
| Odds ratio, group 1 over group 2 | 0.732 | 0.475 | 1.13 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on INTRON A, 5 MIU/m^2 Daily than on PEG-Intron, 6.0 mcg/kg Weekly | 13.4 | 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 | INTRON A, 5 MIU/m^2 Daily | Interferon alfa-2b, recombinant for injection, 5 million international units (MIU)/m\^2, administered daily by SC injection. Treatment was for a minimum of 6 months (mo.) unless there was evidence of disease progression or unacceptable toxicity. | 62 | 173 | EG000 |
| Group 2 | PEG-Intron, 6.0 mcg/kg Weekly | Pegylated interferon alfa-2b, 6.0 microg/kg, administered weekly by subcutaneous (SC) injection. Treatment was for a minimum of 6 months unless there was evidence of disease progression or unacceptable toxicity. | 74 | 171 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to One Year
Source ClinicalTrials.gov
Trial
- Title
- Polyethylene Glycol Interferon Alfa-2b (PEG Intron) Versus Interferon Alfa-2b (INTRON^® A) in the Treatment of Newly Diagnosed Chronic Myelogenous Leukemia (CML) (C98026)
- NCT number
- NCT03547154
- Phases
- PHASE2, PHASE3
- Conditions
- Chronic Myelogenous Leukemia
- Interventions
- Pegylated interferon alfa-2b, Interferon alfa-2b
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2019-08-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03547154?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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