An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 2% 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 (1,463 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2016-03-31, after 2015-10-31 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 2016-03-31. 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: chemotherapycancertherapymetastatichours
Phrases that lowered it: mgsingle dosedayreferenceand safety -
Phase: 3 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 12.5% (raises risk) · Sponsor's track record
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Primary purpose: prevention (lowers risk) · Design
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Drug's FAERS reports with a death: 25.2% (raises risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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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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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports in the prior 12 months: 20239 (lowers risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 5 (raises risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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Drug's FAERS reports marked serious: 92.0% (raises risk) · Drug's FDA history
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Drug's FAERS reports before start: 64799 (lowers risk) · Drug's FDA history
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Collaborators: 1 (raises risk) · Design
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Number of arms: 2 (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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (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
- industry (typical: academic or other)
- Sponsor's past trials
- 8 (typical: 32)
- Sponsor's past termination rate
- 12.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 5 (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
- 64799 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 20239 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 25.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- dexamethasone, palonosetron
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
- An Efficacy and Safety Study of Oral and Intravenous Palonosetron for the Prevention of Nausea and Vomiting NCT01363479 · started 2011 · scored riskier than 65% of active trials completed
- A Study of Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Participants Who Have Experienced CINV(Chemotherapy-Induced Nausea and Vomiting) During the Previous Cycle of Low Emetogenic Chemotherapy (LEC) NCT01054456 · started 2009 · scored riskier than 33% 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
- NEPA Combined With Olanzapine, Dexamethasone-sparing for the Effect of CINV in Patients Receiving HEC Regimens NCT06331520 · started 2024 · scored riskier than 24% of active trials completed
- An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting NCT01339260 · started 2011 · scored riskier than 52% 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.