Clonidine HCl MBT vs. Placebo to Prevent Chemoradiotherapy-Induced Severe Oral Mucositis in Oropharyngeal Cancer.
Model scores of the 29,894 trials active now.
Model score 26% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 34% of the time (35 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2023-05-14, after 2021-02-11 start.
Reason given by the sponsor: “other”
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 2023-05-14. 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) (raises risk) · Wording
Phrases that raised it: cancerinabilityof studystudy drugbearing
Phrases that lowered it: tabletsafety ofevaluatepatients withand safety -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Disease area, cancer: Yes (raises risk) · Disease area
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Phase: 2/3 (raises risk) · Design
-
Drug's FAERS reports with a death: 11.5% (lowers risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
Primary purpose: supportive care (lowers risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Number of arms: 2 (raises risk) · Design
-
Drug's FAERS reports before start: 46724 (lowers risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 69.8% (lowers risk) · Drug's FDA history
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Sponsor's past trials: 0 (raises risk) · Sponsor's track record
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Keywords listed: 11 (raises risk) · Design
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
- 2/3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- supportive care (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 11 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (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
- 46724 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4321 (typical: 412.5)
- Drug's FAERS reports marked serious
- 69.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, digestive
- Drugs matched to FDA substances
- clonidine
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
- Study of the Effects of Brilacidin Oral Rinse on Radiation-induced Oral Mucositis in Patients With Head and Neck Cancer NCT02324335 · started 2014 · scored riskier than 93% of active trials completed
- Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers NCT03515538 · started 2018 · scored riskier than 98% of active trials completed
- Melatonin Oral Gel for Oral Mucositis in Patients With Head and Neck Cancer Undergoing Chemoradiation NCT02630004 · started 2015 · scored riskier than 76% of active trials completed
- A Mouthwash Medicine for the Reduction or Prevention of Mouth Ulceration Caused by Radiotherapy for Head and Neck Cancer NCT06669390 · started 2023 · scored riskier than 50% of active trials completed
- A Study of the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer NCT02508389 · started 2015 · scored riskier than 82% 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.