Study of XP-8121 For the Treatment of Adult Subjects With Hypothyroidism
Model scores of the 29,894 trials active now.
Model score 8% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 15% of the time (7,397 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-02-22, after 2023-05-15 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 2024-02-22. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: to determineplusleast monthstreatmentto assess
Phrases that lowered it: laboratorysinglescreeningopen labelrange -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Design: single group (raises risk) · Design
-
Drug's FAERS reports with a death: 7.0% (lowers risk) · Drug's FDA history
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor's past termination rate: 7.1% (lowers risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 64.8% (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
-
Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Drug's FAERS reports before start: 469410 (lowers risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Blinding: none (lowers risk) · Design
-
Maximum age: 65 (raises risk) · Who can join
-
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
- 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
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 65 (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
- 14 (typical: 32)
- Sponsor's past termination rate
- 7.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 469410 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 35138 (typical: 412.5)
- Drug's FAERS reports marked serious
- 64.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- endocrine
- Drugs matched to FDA substances
- levothyroxine
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
- Bioequivalence of Two Formulations of Levothyroxine Sodium 200 Micrograms (mcg) Under Tablet Form NCT04037748 · started 2019 · scored riskier than 0% of active trials completed
- A Phase 1 Study of TE-8214 Solution in Healthy Volunteers NCT06372652 · started 2024 · scored riskier than 5% of active trials completed
- Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation NCT01916304 · started 2013 · scored riskier than 23% of active trials completed
- BE of Euthyrox® Tablets (Merck Nantong Versus Merck Darmstadt Sites) NCT05174000 · started 2022 · scored riskier than 0% of active trials completed
- Tolerability, Safety and Pharmacokinetics Study of GX-30 in Total Thyroidectomy or Near Total Thyroidectomy Patients NCT03276988 · started 2017 · scored riskier than 8% 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.