To Investigate the Effect of Intravenous Ondansetron on Cardiac Conduction as Compared to Placebo and Moxifloxacin in Healthy Adult Subjects
Model scores of the 29,894 trials active now.
Model score 5% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 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 2011-12-19, after 2011-08-16 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 2011-12-19. 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: Yes (lowers risk) · Who can join
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Design: crossover (lowers risk) · Design
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Primary purpose: other (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 451 (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: qtplaceboto administrationsyndromeevidence
Phrases that lowered it: healthyscreeningkgperiodbody -
Sponsor's past termination rate: 4.8% (lowers risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Sponsor's past trials: 1444 (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Number of arms: 4 (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Blinding: double (raises risk) · Design
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Drug's FAERS reports with a death: 18.5% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports before start: 7414 (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
- 1 (typical: 2)
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- other (typical: treatment)
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 45 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 1444 (typical: 32)
- Sponsor's past termination rate
- 4.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 451 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 7414 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1849 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 18.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- moxifloxacin, 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
- This Study Will Investigate the Effect of Single Oral Doses of Retosiban on Cardiac Repolarization, With Moxifloxacin as a Positive Control in Healthy Volunteers. NCT01702376 · started 2012 · scored riskier than 3% of active trials completed
- Study to Investigate the Effect of BL-8040 (Motixafortide) on the QTc Interval in Healthy Subjects NCT05293171 · started 2021 · scored riskier than 4% of active trials completed
- Placebo-Corrected Effects of Therapeutic Dose (100 mg) and Supratherapeutic Dose (300 mg) of ITF2357 (Givinostat) and Moxifloxacin on QT/QTC Interval NCT04821063 · started 2021 · scored riskier than 3% of active trials completed
- A Study to Evaluate the Effect of Losmapimod on Cardiac Conduction as Compared to Placebo and Moxifloxacin NCT01756495 · started 2013 · scored riskier than 6% of active trials completed
- Placebo and Moxifloxacin Controlled Cardiac Conduction Study of GSK2140944 in Healthy Volunteers NCT02257398 · started 2014 · scored riskier than 3% 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.