Comparison · NCT03439137-sae
MT-6548 vs Darbepoetin Alfa: 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. MT-6548 vs Darbepoetin Alfa: serious adverse events. Trial comparisons, record NCT03439137-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03439137-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 | 0.253 | 0.192 | 0.325 | wilson | |
| Risk in group 2 | 0.273 | 0.21 | 0.347 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0202 | -0.116 | 0.0755 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.926 | 0.643 | 1.33 | log | |
| Odds ratio, group 1 over group 2 | 0.901 | 0.549 | 1.48 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on MT-6548 than on Darbepoetin Alfa | 49.5 | 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 | MT-6548 | MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.~Darbepoetin alfa matching placebo: Intravenous administration | 41 | 162 | EG000 |
| Group 2 | Darbepoetin Alfa | Darbepoetin alfa: Intravenous administration. The dose was adjusted to 5-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.~MT-6548-matching placebo: Oral tablet | 44 | 161 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 52 weeks
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan
- NCT number
- NCT03439137
- Phases
- PHASE3
- Conditions
- Anemia; Hemodialysis Dependent Chronic Kidney Disease
- Interventions
- MT-6548, Darbepoetin alfa, MT-6548-matching placebo, Darbepoetin alfa-matching placebo
- Lead sponsor
- Tanabe Pharma Corporation
- Results first posted
- 2021-04-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03439137?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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