An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Participants With Euvolemic or Hypervolemic Hyponatremia
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 9% of the time (803 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2017-10-23, after 2016-04-22 start.
Reason given by the sponsor: “enrollment”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2017-10-23. 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: hoursthe triallocalpostoperative
Phrases that lowered it: safety ofparticipantsserumulnblood pressure -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 9.2% (raises risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 33.2% (raises risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: single group (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 22 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Maximum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 95.7% (raises risk) · Drug's FDA history
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Sponsor's past trials: 142 (lowers risk) · Sponsor's track record
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Collaborators: 1 (raises risk) · Design
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Drug's FAERS reports before start: 2032 (raises risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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
- 3 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 9 (typical: 1)
Who can join
- Minimum age
- 4 (typical: 18)
- Maximum age
- 18 (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
- 142 (typical: 32)
- Sponsor's past termination rate
- 9.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 22 (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
- 2032 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 613 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 33.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic
- 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
- A PK Study of 3 Dosages of Tolvaptan in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) NCT02009878 · started 2013 · scored riskier than 30% 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
- Safety and Pharmacokinetics of MK-2060 in Older Participants With End-Stage Renal Disease on Hemodialysis (MK-2060-004) NCT03873038 · started 2019 · scored riskier than 29% of active trials completed
- Probenecid (PB) to Treat Hereditary Nephrogenic Diabetes Insipidus (NDI), ADPKD Treated With Tolvaptan, and Severely Polyuric Patients With Previous Lithium Administration NCT05190744 · started 2022 · scored riskier than 77% of active trials completed
- A Study of TAK-536 in Children From 2 to Less Than 6 Years Old With High Blood Pressure NCT04668157 · started 2021 · scored riskier than 29% 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.