Comparison · NCT00413777-sae
Tolvaptan 45+15 mg vs Tolvaptan 60+30 mg: 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 45+15 mg vs Tolvaptan 60+30 mg: serious adverse events. Trial comparisons, record NCT00413777-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00413777-sae
On this page
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 | 0.136 | 0.0475 | 0.333 | wilson | |
| Risk in group 2 | 0.333 | 0.18 | 0.533 | wilson | |
| Risk difference, group 1 minus group 2 | -0.197 | -0.415 | 0.0528 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.409 | 0.124 | 1.35 | log | |
| Odds ratio, group 1 over group 2 | 0.316 | 0.0716 | 1.39 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Tolvaptan 45+15 mg than on Tolvaptan 60+30 mg | 5.08 | 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 | Tolvaptan 45+15 mg | Participants had received tolvaptan tablets of 45+15 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months. | 3 | 22 | EG000 |
| Group 2 | Tolvaptan 60+30 mg | Participants had received tolvaptan tablets of 60+30 mg orally twice daily during the fixed-dose period from Month 2 to Month 36 followed by a planned extension period for an additional 12 Months. | 8 | 24 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- AEs were recorded from screening (ICF was signed) until 7-days of safety follow-up. Participants with AEs in multiple system organ classes were counted only once towards the total.
Source ClinicalTrials.gov
Trial
- Title
- Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- NCT number
- NCT00413777
- Phases
- PHASE2
- Conditions
- Polycystic Kidney, Autosomal Dominant
- Interventions
- Tolvaptan
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Results first posted
- 2017-07-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00413777?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
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT00413777-sae