A Trial Investigating Lu AF28996 in Healthy Adult Participants
Model scores of the 29,894 trials active now.
Model score 3% for any early termination, 1% 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 2024-05-19, after 2024-02-27 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 2024-05-19. 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: baselinenotehormonaleffectsfollowing
Phrases that lowered it: healthyparticipantparticipantssingle dosevisit -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Sponsor's past termination rate: 21.9% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Drug's FAERS reports with a death: 9.4% (lowers risk) · Drug's FDA history
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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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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports before start: 688678 (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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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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Design: sequential (lowers risk) · Design
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Drug's FAERS reports marked serious: 73.8% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 11 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 155 (lowers risk) · Sponsor's track record
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Disease area, psychiatry: 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
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (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
- 155 (typical: 32)
- Sponsor's past termination rate
- 21.9% (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
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 688678 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 35147 (typical: 412.5)
- Drug's FAERS reports marked serious
- 73.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- amoxicillin clavulanate, amoxicillin clavulanic acid, aspirin, mefenamic acid
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 the Movement of Lu AF28996 Into, Through, and Out of the Body of Healthy Men NCT06337110 · started 2024 · scored riskier than 3% of active trials completed
- A Study to Evaluate Lu AF90103 in Healthy Men NCT04940949 · started 2021 · scored riskier than 12% of active trials terminated
- Study Investigating the Safety and Tolerability of Lu AF88434 in Healthy Young Men NCT04082325 · started 2019 · scored riskier than 5% of active trials completed
- Effects of Repeated Doses of Lu AF35700 on Drug Metabolizing Enzymes NCT03195946 · started 2017 · scored riskier than 3% of active trials completed
- Safety and Tolerability of Lu AF95245 in Healthy Young Men NCT04199585 · started 2019 · scored riskier than 4% 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.