Comparison · NCT01439009-sae
Tolvaptan vs Placebo: 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. Tolvaptan vs Placebo: serious adverse events. Trial comparisons, record NCT01439009-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01439009-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 | 0.48 | 0.348 | 0.615 | wilson | |
| Risk in group 2 | 0.44 | 0.312 | 0.577 | wilson | |
| Risk difference, group 1 minus group 2 | 0.04 | -0.15 | 0.226 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.09 | 0.713 | 1.67 | log | |
| Odds ratio, group 1 over group 2 | 1.17 | 0.535 | 2.58 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Tolvaptan than on Placebo | 25 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Tolvaptan | 15 mg~Tolvaptan: Once-daily oral administration of one tolvaptan 15 mg tablet in the morning | 24 | 50 | EG000 |
| Group 2 | Placebo | Placebo~Placebo of tolvaptan: Once-daily oral administration of one placebo tablet in the morning | 22 | 50 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 26 weeks
Source ClinicalTrials.gov
Trial
- Title
- Effect of Tolvaptan on Mid- to Long-term Prognosis of Heart Failure Patients
- NCT number
- NCT01439009
- Phases
- PHASE4
- Conditions
- Heart Failure
- Interventions
- Tolvaptan, Placebo of tolvaptan
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Results first posted
- 2019-10-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01439009?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT01439009-sae