8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 17% of the time (192 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
Completed on 2013-07-31, after 2011-10-31 start.
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 2013-07-31. 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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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: mrikidneydiseasecancerrandomization
Phrases that lowered it: subjectsmedical historymmhgm2and safety -
Phase: 2 (raises risk) · Design
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Drug's FAERS reports with a death: 43.0% (raises risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Blinding: triple (raises risk) · Design
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Number of arms: 4 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 31 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Maximum age: 50 (lowers risk) · Who can join
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Minimum age: 18 (raises risk) · Who can join
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Sponsor's past trials: 73 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 93.4% (raises risk) · Drug's FDA history
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Collaborators: 0 (raises risk) · Design
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
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 50 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 73 (typical: 32)
- Sponsor's past termination rate
- 8.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 31 (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
- 151 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 104 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 43.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- 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
- Tolvaptan Extension Study in Participants With ADPKD NCT01214421 · started 2010 · scored riskier than 52% of active trials completed
- Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease) NCT02964273 · started 2016 · scored riskier than 85% of active trials completed
- Tolvaptan-Octreotide LAR Combination in ADPKD NCT03541447 · started 2018 · scored riskier than 37% of active trials completed
- Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease NCT02251275 · started 2014 · scored riskier than 39% of active trials completed
- Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease NCT02160145 · started 2014 · scored riskier than 36% 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.