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Comparison · NCT04064346-ab40b70b

Lixivaptan vs Placebo: Number of Participants With TEAEs After Randomization in Part 1

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Lixivaptan vs Placebo: Number of Participants With TEAEs After Randomization in Part 1. Trial comparisons, record NCT04064346-ab40b70b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04064346-ab40b70b

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.250.04560.699wilson
Risk in group 210.2071wilson
Risk difference, group 1 minus group 2-0.75-0.9540.162newcombe hybrid score
Risk ratio, group 1 over group 20.250.04581.36log
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treat, for one fewer participant with the outcome on Lixivaptan than on Placebo1.33from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1LixivaptanLixivaptan capsules, 100-200 mg twice a day (BID)~Lixivaptan: Oral vasopressin V2 receptor antagonist14OG000
Group 2PlaceboMatching placebo capsules BID~Placebo: Matching placebo11OG001

Outcome

Type
SECONDARY
Title
Number of Participants With TEAEs After Randomization in Part 1
Description
Number of participants with TEAEs by treatment group after Randomization (Double-blind Randomized Treatment Period and Follow-up Period I)
Time frame
From Randomization to study completion (up to 102 days)
Population
All participants who were randomized.

Source ClinicalTrials.gov

Trial

Title
Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney Disease
NCT number
NCT04064346
Phases
PHASE3
Conditions
Autosomal Dominant Polycystic Kidney, ADPKD
Interventions
Lixivaptan, Placebo
Lead sponsor
Palladio Biosciences
Results first posted
2023-02-06

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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