Comparison · NCT00428948-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 NCT00428948-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00428948-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 | 0.184 | 0.161 | 0.21 | wilson | |
| Risk in group 2 | 0.197 | 0.164 | 0.234 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0125 | -0.0569 | 0.0294 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.936 | 0.748 | 1.17 | log | |
| Odds ratio, group 1 over group 2 | 0.922 | 0.699 | 1.22 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Tolvaptan than on Placebo | 80 | 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 | Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months. | 177 | 961 | EG000 |
| Group 2 | Placebo | Participants received placebo (upon awakening and 9 hours later) orally for 36 months. | 95 | 483 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected from the time of signing the informed consent, throughout the 3 year treatment period and up to 42 days after the last dose of study medication
Source ClinicalTrials.gov
Trial
- Title
- Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- NCT number
- NCT00428948
- Phases
- PHASE3
- Conditions
- Polycystic Kidney Disease, Autosomal Dominant
- Interventions
- Tolvaptan, Placebo
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Results first posted
- 2017-07-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00428948?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/NCT00428948-sae