Comparison · NCT01074307-sae
Low Dose Bisoprolol vs High Dose Bisoprolol: 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. Low Dose Bisoprolol vs High Dose Bisoprolol: serious adverse events. Trial comparisons, record NCT01074307-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01074307-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 | 0.242 | 0.155 | 0.358 | wilson | |
| Risk in group 2 | 0.0789 | 0.0421 | 0.143 | wilson | |
| Risk difference, group 1 minus group 2 | 0.163 | 0.055 | 0.285 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.07 | 1.44 | 6.55 | log | |
| Odds ratio, group 1 over group 2 | 3.73 | 1.54 | 9.03 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Low Dose Bisoprolol than on High Dose Bisoprolol | 6.12 | 3.51 | 18.2 | 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 | Low Dose Bisoprolol | Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks. | 16 | 66 | EG000 |
| Group 2 | High Dose Bisoprolol | Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks. | 9 | 114 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline up to Week 26
Source ClinicalTrials.gov
Trial
- Title
- A Prospective, Open-labeled, Multi-centric Trial in Subjects With Systolic Heart Failure to Evaluate Bisoprolol Treatment for the Effects on Surrogate Markers of Heart Failure in Korea
- NCT number
- NCT01074307
- Phases
- PHASE4
- Conditions
- Heart Failure, Congestive
- Interventions
- Low Dose Bisoprolol, High Dose Bisoprolol
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Results first posted
- 2014-02-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01074307?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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