Ondansetron for Pediatric Mild Traumatic Brain Injury
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (201 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
Completed on 2014-02-28, after 2013-03-31 start.
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 2014-02-28. 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: controlledprimarybrainplacebopost
Phrases that lowered it: patients whoagedparticipantsweekcompare -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1 (lowers risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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Sponsor's past termination rate: 6.7% (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 23.1% (raises risk) · Drug's FDA history
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Blinding: quadruple (lowers risk) · Design
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Maximum age: 17 (raises risk) · Who can join
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Minimum age: 8 (raises risk) · Who can join
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Responsible party: principal investigator (lowers risk) · Design
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Sponsor's past trials: 15 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 93.0% (raises risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Collaborators: 0 (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
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 8 (typical: 18)
- Maximum age
- 17 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 15 (typical: 32)
- Sponsor's past termination rate
- 6.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 10 (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
- 10209 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3054 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 23.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology
- Drugs matched to FDA substances
- ondansetron
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
- Amitriptyline to Prevent Headache After Traumatic Brain Injury NCT01856270 · started 2013 · scored riskier than 49% of active trials completed
- DHA For The Treatment of Pediatric Concussion Related to Sports Injury NCT01903525 · started 2013 · scored riskier than 76% of active trials completed
- PTSD Prevention Using Oral Hydrocortisone NCT04924166 · started 2022 · scored riskier than 67% of active trials completed
- Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA NCT02160535 · started 2014 · scored riskier than 69% of active trials terminated
- Study of NNZ-2566 in Patients With Traumatic Brain Injury Under EFIC NCT01366820 · started 2013 · scored riskier than 66% 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.