GEM/Cisplatin/S-1 vs GEM/Cisplatin for Biliary Tract Cancer
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 10% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (607 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 2018-04-16, after 2014-07-09 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 2018-04-16. 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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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Minimum age: 20 (lowers risk) · Who can join
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cancercisplatinpatientsdiabetesmellitus
Phrases that lowered it: pulmonaryhistorymm3severe150 -
Phase: 3 (lowers risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 24.4% (raises risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 96.3% (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Sponsor's past trials: 3 (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 2 (raises risk) · Design
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Blinding: none (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
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 20 (typical: 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
- 3 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 4 (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
- 31883 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3709 (typical: 412.5)
- Drug's FAERS reports marked serious
- 96.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 24.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, digestive
- Drugs matched to FDA substances
- cisplatin, gemcitabine
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
- Randomized Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer NCT01096745 · started 2010 · scored riskier than 26% of active trials terminated
- Gemcitabine/Cisplatin/S-1(GCS) Combination Therapy for Patients With Advanced Biliary Tract Cancer NCT01284413 · started 2010 · scored riskier than 47% of active trials completed
- Trial of S-1 Plus Cisplatin (SP) Versus Gemcitabine Plus Cisplatin (GP) in Advanced Biliary Tract Adenocarcinoma NCT01375972 · started 2008 · scored riskier than 76% of active trials completed
- Gemcitabine and Cetuximab in Patients With Advanced or Metastatic Biliary Tract Cancer: A Multicenter Phase II Study NCT00747097 · started 2008 · scored riskier than 39% of active trials completed
- Chemoradiotherapy With Gemcitabine/S-1 vs Gemcitabine/S-1 for Locally Advanced Pancreatic Cancer NCT01430052 · started 2009 · scored riskier than 50% 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.