Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 9% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (313 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-07-06, after 2019-09-14 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 2024-07-06. 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: acutehoursplacebointravenoussyndrome
Phrases that lowered it: trialacidhistory orallergicphase iii -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 11.9% (raises risk) · Sponsor's track record
-
Collaborators: 10 (lowers risk) · Design
-
Phase: 3 (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 59 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 13.3% (lowers risk) · Drug's FDA history
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Minimum age: 0.5 (lowers risk) · Who can join
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Blinding: quadruple (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 17259 (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 84361 (lowers risk) · Drug's FDA history
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Sponsor's past trials: 177 (lowers risk) · Sponsor's track record
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Maximum age: 17 (raises risk) · Who can join
-
Keywords listed: 6 (lowers risk) · Design
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Drug's FAERS reports marked serious: 79.2% (lowers risk) · Drug's FDA history
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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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 10 (typical: 0)
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 0.5 (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
- 177 (typical: 32)
- Sponsor's past termination rate
- 11.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 59 (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
- 84361 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 17259 (typical: 412.5)
- Drug's FAERS reports marked serious
- 79.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 13.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, digestive
- 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
- Symptomatic Treatment of Acute Gastroenteritis NCT01257672 · started 2011 · scored riskier than 75% of active trials completed
- Efficacy of Ondansetron on Vomiting Due to Acute Gastroenteritis in Pediatric During Winter NCT02028910 · started 2014 · scored riskier than 51% of active trials terminated
- Triage Administration of Ondansetron for Gastroenteritis in Children NCT03052361 · started 2017 · scored riskier than 77% of active trials terminated
- A Study to Evaluate the Safety and Efficacy of Domperidone in Pediatric Participants With Nausea and Vomiting Due to Acute Gastroenteritis NCT02699385 · started 2015 · scored riskier than 24% of active trials terminated
- BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis NCT02246439 · started 2014 · scored riskier than 26% 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.