Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)
Model scores of the 29,894 trials active now.
Model score 24% 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 15% of the time (734 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-04-21, after 2022-04-27 start.
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 2023-04-21. 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: subjects withdementiasubjects whoassociatedacute
Phrases that lowered it: participantsand safetyefficacyperiod28 -
Sponsor's past termination rate: 16.7% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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Design: parallel (raises risk) · Design
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Phase: 3 (lowers risk) · Design
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Minimum age: 65 (raises risk) · Who can join
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Maximum age: not given (lowers risk) · Who can join
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Drug's FAERS reports marked serious: 93.6% (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Sponsor's past trials: 6 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 16.2% (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 3886 (raises risk) · Drug's FDA history
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Keywords listed: 0 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 3 (lowers risk) · Sponsor's track record
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Blinding: double (raises risk) · Design
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Collaborators: 1 (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
- 3 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 65 (typical: 18)
- Maximum age
- not given (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
- 6 (typical: 32)
- Sponsor's past termination rate
- 16.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 3 (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
- 3886 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 702 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 16.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, psychiatry
- Drugs matched to FDA substances
- dexmedetomidine
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
- Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III) NCT05665088 · started 2022 · scored riskier than 87% of active trials terminated
- An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia NCT05276830 · started 2022 · scored riskier than 70% of active trials terminated
- Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia NCT04251910 · started 2019 · scored riskier than 13% of active trials completed
- Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type NCT01922258 · started 2013 · scored riskier than 58% of active trials completed
- A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation NCT01862640 · started 2013 · scored riskier than 82% 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.