Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 11% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (136 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2023-12-31, after 2021-08-13 start.
Reason given by the sponsor: “safety”
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 2023-12-31. 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: subjectscrohnsubjectscreeningpediatric
Phrases that lowered it: receivedqttreatment withwithin 1414 days -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Collaborators: 3 (lowers risk) · Design
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Phase: 2 (raises risk) · Design
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Sponsor's past termination rate: 8.6% (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 107 (lowers risk) · Sponsor's track record
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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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Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 9.7% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Maximum age: 17 (raises risk) · Who can join
-
Minimum age: 3 (lowers risk) · Who can join
-
Sponsor's past trials: 648 (raises risk) · Sponsor's track record
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Drug's FAERS reports in the prior 12 months: 16085 (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 77.4% (lowers risk) · Drug's FDA history
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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
- 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
- 3 (typical: 0)
- Keywords listed
- 1
Who can join
- Minimum age
- 3 (typical: 18)
- Maximum age
- 17 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 648 (typical: 32)
- Sponsor's past termination rate
- 8.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 107 (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
- 117994 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 16085 (typical: 412.5)
- Drug's FAERS reports marked serious
- 77.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive
- Drugs matched to FDA substances
- azithromycin, metronidazole
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
- Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease NCT02765256 · started 2016 · scored riskier than 35% of active trials completed
- FMT in Pediatric Crohn's Disease NCT03194529 · started 2017 · scored riskier than 82% of active trials completed
- Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease NCT03476317 · started 2018 · scored riskier than 56% of active trials completed
- Fecal Microbiota Transplant (FMT) in Pediatric Active Ulcerative Colitis and Pediatric Active Crohn's Colitis NCT02330653 · started 2015 · scored riskier than 56% of active trials completed
- Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor (Anti-TNF) Therapy NCT02772965 · started 2016 · scored riskier than 60% 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.