Tolvaptan for In-hospital Hyponatremia
Model scores of the 29,894 trials active now.
Model score 25% for any early termination, 12% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (453 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Terminated on 2012-11-30, after 2011-06-30 start.
Reason given by the sponsor: “efficacy”
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2012-11-30. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: ventricularserumheart failureuncontrolledangina
Phrases that lowered it: multipleopenevaluateand safetyabuse -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 9.1% (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Drug's FAERS reports with a death: 44.5% (raises risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports marked serious: 91.8% (raises risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Collaborators: 1 (raises risk) · Design
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Maximum age: 80 (lowers risk) · Who can join
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Blinding: none (raises risk) · Design
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Disease area, metabolic: Yes (lowers risk) · Disease area
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 80 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 11 (typical: 32)
- Sponsor's past termination rate
- 9.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 11 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 110 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 83 (typical: 412.5)
- Drug's FAERS reports marked serious
- 91.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 44.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, metabolic, urogenital, endocrine
- Drugs matched to FDA substances
- tolvaptan
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia NCT01227512 · started 2010 · scored riskier than 62% of active trials terminated
- Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Lixivaptan Capsules in Subject With Euvolemic Hyponatremia NCT00660959 · started 2008 · scored riskier than 94% of active trials completed
- Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia NCT02012959 · started 2015 · scored riskier than 34% of active trials terminated
- A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects With Euvolemic Hyponatremia NCT00876798 · started 2009 · scored riskier than 58% of active trials completed
- A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH NCT03048747 · started 2017 · scored riskier than 7% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.