A Study of Capecitabine Rapid Disintegrating Tablets (RDT) Versus Commercial Xeloda in Patients With Solid Tumours
Model scores of the 29,894 trials active now.
Model score 8% 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 16% of the time (1,938 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 2012-10-31, after 2012-05-31 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 2012-10-31. 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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Design: crossover (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1 (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: transplantrandomizedsyndromesubjects withautologous
Phrases that lowered it: tabletsdayopensingle dosedrug -
Has a data monitoring committee: not given (lowers risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Sponsor's past termination rate: 9.8% (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 29.7% (raises risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 206 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 523 (raises risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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Disease area, digestive: Yes (raises risk) · Disease area
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Maximum age: not given (raises risk) · Who can join
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
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 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
- 523 (typical: 32)
- Sponsor's past termination rate
- 9.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 206 (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
- 15933 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2959 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 29.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, digestive, dermatology
- Drugs matched to FDA substances
- capecitabine
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
- Pharmacokinetic and Safety Comparison of Two Capecitabine Tablets in Patients With Colorectal or Breast Cancer NCT04420871 · started 2018 · scored riskier than 10% of active trials completed
- A Bioequivalence Study of Capecitabine Tablets NCT01846650 · started 2012 · scored riskier than 10% of active trials completed
- A Trial Comparing S1 Generic With Capecitabine in Metastatic Breast Cancer (MBC) NCT01655992 · started 2012 · scored riskier than 57% of active trials terminated
- A Study of ARRY-334543 and Capecitabine in Patients With Advanced Cancer NCT00710736 · started 2008 · scored riskier than 59% of active trials completed
- Safety, Tolerability and Pharmacokinetics of Oral Tablet of Irinotecan in Adult Patients With Solid Tumors NCT03295084 · started 2015 · 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.