Effectiveness of Aprepitant in Addition to Ondansetron in the Prevention of Nausea and Vomiting Caused by Upper Abdominal Radiotherapy
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 16% of the time (1,198 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 2016-08-01, after 2009-10-31 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 2016-08-01. 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: radiationbowelinrtumorvomiting
Phrases that lowered it: gemcitabineperiodstudyadministration ofsingle -
Phase: 2 (raises risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Collaborators: 4 (lowers risk) · Design
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Design: single group (raises risk) · Design
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Has a data monitoring committee: Yes (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: 16.0% (lowers risk) · Drug's FDA history
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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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Sponsor's past termination rate: 7.1% (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Number of arms: 1 (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 15 (lowers risk) · Sponsor's track record
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Responsible party: principal investigator (lowers risk) · Design
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Disease area, dermatology: 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
- 2
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 4 (typical: 0)
- Keywords listed
- 5 (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
- academic or other
- Sponsor's past trials
- 14 (typical: 32)
- Sponsor's past termination rate
- 7.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 15 (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
- 4247 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1143 (typical: 412.5)
- Drug's FAERS reports marked serious
- 88.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 16.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- aprepitant, 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
- Emend and Ondansetron Compared to Ondansetron Alone to Prevent CINV in Glioma Patients Receiving Temozolomide NCT01450826 · started 2014 · scored riskier than 76% of active trials completed
- Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Healthy Adult Volunteers NCT03245918 · started 2017 · scored riskier than 1% of active trials completed
- PK/PD Study of Netupitant and Palonosetron in Pediatric Patients for Prevention of Chemotherapy-induced Nausea and Vomiting NCT03204279 · started 2017 · scored riskier than 20% of active trials completed
- Adding Mirtazapine to Dexamethasone and Aprepitant for Delayed Emesis NCT02336750 · started 2014 · scored riskier than 42% of active trials completed
- A Safety Study of Intravenous Pro-Netupitant and Palonosetron Combination for the Prevention of Nausea and Vomiting NCT02517021 · started 2015 · scored riskier than 43% 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.