A Study to Evaluate a New Tablet Formulation of Lu AG06466 in Healthy Participants
Model scores of the 29,894 trials active now.
Model score 2% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-12-29, after 2021-08-23 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 2021-12-29. 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) (lowers risk) · Wording
Phrases that raised it: participantparticipantsor psychiatricresearchersnew
Phrases that lowered it: tablethealthydisorderformulationvisit -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Design: crossover (lowers risk) · Design
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Sponsor's past termination rate: 20.7% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Has a data monitoring committee: not given (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 32 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 12.8% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Maximum age: 55 (lowers risk) · Who can join
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Blinding: none (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 80.5% (lowers risk) · Drug's FDA history
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Number of arms: 4 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Disease area, psychiatry: No (lowers risk) · Disease area
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Disease area, neurology: No (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
- 1 (typical: 2)
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 55 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 121 (typical: 32)
- Sponsor's past termination rate
- 20.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 32 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 21215 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2003 (typical: 412.5)
- Drug's FAERS reports marked serious
- 80.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- aluminum hydroxide, aluminum hydroxide hydroxide, hydroxide
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 Study Investigating Lu AG06474 in Healthy Young Participants NCT05943327 · started 2023 · scored riskier than 3% of active trials terminated
- Safety and Tolerability of Lu AG06474 in Healthy Young Men NCT05003687 · started 2021 · scored riskier than 4% of active trials completed
- Safety and Tolerability Study of Lu AG06466 in Healthy Young Japanese and Caucasian Participants NCT05177029 · started 2021 · scored riskier than 7% of active trials terminated
- A Trial Investigating the Pain-relieving Properties of Lu AG06474 in Healthy Adult Participants NCT06077786 · started 2023 · scored riskier than 4% of active trials completed
- Safety and Tolerability of Lu AG06479 in Healthy Young Men NCT04473651 · started 2020 · scored riskier than 6% of active trials terminated
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.