Randomized Trial of Glutamine in Patients With Mucositis or Esophagitis
Model scores of the 29,894 trials active now.
Model score 23% for any early termination, 22% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 19% of the time (90 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 2021-03-03, after 2014-07-10 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 2021-03-03. 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) (raises risk) · Wording
Phrases that raised it: radiationpatients musttherapyregimenchemotherapy
Phrases that lowered it: drugeffectesophagitisoralclinical -
Sponsor's past termination rate: 28.9% (raises risk) · Sponsor's track record
-
Phase: 3 (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Design: parallel (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 158 (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 17.1% (lowers risk) · Drug's FDA history
-
Disease area, cancer: No (lowers risk) · Disease area
-
Keywords listed: 17 (lowers risk) · Design
-
Drug's FAERS reports marked serious: 73.5% (lowers risk) · Drug's FDA history
-
Sponsor's past trials: 474 (lowers risk) · Sponsor's track record
-
Minimum age: 17 (raises risk) · Who can join
-
Primary purpose: supportive care (lowers risk) · Design
-
Collaborators: 1 (raises risk) · Design
-
Drug's FAERS reports before start: 298 (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
- 3 (typical: 2)
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- supportive care (typical: treatment)
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 17 (typical: 1)
Who can join
- Minimum age
- 17 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 474 (typical: 32)
- Sponsor's past termination rate
- 28.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 158 (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
- 298 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 70 (typical: 412.5)
- Drug's FAERS reports marked serious
- 73.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 17.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive
- Drugs matched to FDA substances
- glutamine
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
- Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis NCT06031012 · started 2023 · scored riskier than 22% 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
- 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 Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer NCT01746043 · started 2013 · scored riskier than 99% of active trials completed
- Dexamethasone in Reducing Everolimus-Induced Oral Stomatitis in Patients With Cancer NCT03839940 · started 2019 · scored riskier than 48% 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.