A Safety and Tolerability Study of Otelixizumab in Thyroid Eye Disease
Model scores of the 29,894 trials active now.
Model score 11% 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 16% of the time (369 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Terminated on 2012-08-29, after 2010-07-07 start.
Reason given by the sponsor: “other”
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2012-08-29. 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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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: evidencedefineddose oflast doseof study
Phrases that lowered it: periodvaccinescreeninginclusiveday -
Has a data monitoring committee: not given (lowers risk) · Design
-
Sponsor's past termination rate: 4.4% (lowers risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Sponsor's past trials: 1208 (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 439 (raises risk) · Sponsor's track record
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Blinding: single (lowers risk) · Design
-
Number of arms: 3 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
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Disease area, neurology: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 93.5% (raises risk) · Drug's FDA history
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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- single (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 10 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 75 (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
- 1208 (typical: 32)
- Sponsor's past termination rate
- 4.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 439 (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
- 12066 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2459 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 20.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- immunology, endocrine
- Drugs matched to FDA substances
- methylprednisolone
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
- Investigation of Otelixizumab in New-Onset, Autoimmune Type 1 Diabetes Mellitus Patients NCT02000817 · started 2014 · scored riskier than 24% of active trials completed
- Investigating Re-Dosing With Otelixizumab in Adults With Newly-Diagnosed Type 1 Diabetes Mellitus NCT01222078 · started 2010 · scored riskier than 20% of active trials terminated
- Comparative Study of 3 Tocilizumab Products in Normal Healthy Volunteeers NCT04885829 · started 2021 · scored riskier than 2% of active trials completed
- Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study NCT03298867 · started 2017 · scored riskier than 42% of active trials completed
- Study of Induction of Hypothyroxinemia Adjunct to Conventional Therapies in GBM Patients NCT02654041 · started 2016 · scored riskier than 75% 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.