Open, Single-dose/-Period Study to Assess Mass Balance Recovery, Metabolite Profile/Identification of 14C-Varlitinib
Model scores of the 29,894 trials active now.
Model score 3% 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 11% of the time (918 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2017-12-14, after 2017-11-23 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 2017-12-14. 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: subjects withradiationheartdiseasefailure
Phrases that lowered it: healthysingleopen labelmalejudged -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Minimum age: 30 (lowers risk) · Who can join
-
Design: single group (raises risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Has a data monitoring committee: not given (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
-
Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
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Blinding: none (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record
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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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- basic science (typical: 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
- 30 (typical: 18)
- Maximum age
- 65 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 7 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 4 (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
- 2 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- varlitinib
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
- Excretion Balance, Pharmacokinetics, and Metabolism Following of [14C]-Venglustat Administration in Healthy Male Subjects NCT05238714 · started 2020 · scored riskier than 2% of active trials completed
- Absolute Bioavailability and ADME Study of Savolitinib in Healthy Male Subjects NCT04675021 · started 2020 · scored riskier than 4% of active trials completed
- Single Dose Study of [14C]-IDV184001AN ([14C]-IDV184001) in Healthy Adult Male Participants NCT05974046 · started 2023 · scored riskier than 3% of active trials completed
- A Study to Assess the Mass Balance Recovery, Pharmacokinetics, Metabolite Profile and Metabolite Identification of [14C]AZD4831 NCT04407091 · started 2020 · scored riskier than 4% of active trials completed
- A Study to Assess the Mass Balance Recovery and Metabolite Profile & Identification of [14C]-APX001 in Healthy Males NCT04804059 · started 2018 · scored riskier than 2% 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.