A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 23% of the time (1,629 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 2021-06-30, after 2013-12-31 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 2021-06-30. 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: metastaticpancreaticadenocarcinomacancerpatient
Phrases that lowered it: safety offemaleof ageyears ofnon -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 12.5% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Design: single group (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Has a data monitoring committee: Yes (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 7 (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports before start: 44822 (lowers risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 6865 (lowers risk) · Drug's FDA history
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Number of arms: 1 (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
-
Drug's FAERS reports with a death: 22.5% (raises risk) · Drug's FDA history
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Drugs with FDA adverse-event history: 4 (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 93.6% (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
- 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
- sponsor
- Collaborators
- 0
- Keywords listed
- 6 (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
- 16 (typical: 32)
- Sponsor's past termination rate
- 12.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 7 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 44822 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6865 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 22.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, digestive, endocrine
- Drugs matched to FDA substances
- anakinra, fluorouracil, irinotecan, oxaliplatin
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
- A Study of Abemaciclib (LY2835219) Alone or in Combination With Other Agents in Participants With Previously Treated Pancreatic Ductal Adenocarcinoma NCT02981342 · started 2017 · scored riskier than 67% of active trials completed
- Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced, Unresectable Pancreatic Cancer NCT03941093 · started 2019 · scored riskier than 29% of active trials completed
- Nab-Pac+Cis+Gem in Pts w Previously Untreated Metastatic PDA NCT01893801 · started 2013 · scored riskier than 77% of active trials completed
- Nab-paclitaxel (Abraxane), Gemcitabine, and Capecitabine (Xeloda) for Pancreatic Adenocarcinoma NCT01161186 · started 2010 · scored riskier than 71% of active trials completed
- Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine For The First Line Treatment of Pancreas Cancer NCT03807999 · 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.