Safety and Efficacy of Multiple Daily Dosing of Oral LFF571 in Patients With Moderate Clostridium Difficile Infections
Model scores of the 29,894 trials active now.
Model score 15% 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 8% of the time (780 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 2013-07-31, after 2010-10-31 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 2013-07-31. 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
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 10.9% (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
-
Blinding: single (lowers risk) · Design
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: to determineother protocoleffectiveprotocol defineddefined inclusion
Phrases that lowered it: moderatepatients whoefficacydailysafety -
Design: parallel (raises risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
-
Number of arms: 6 (lowers risk) · Design
-
Drug's FAERS reports with a death: 24.4% (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 260 (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
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Maximum age: 90 (lowers risk) · Who can join
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Sponsor's past trials: 247 (lowers risk) · Sponsor's track record
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Keywords listed: 8 (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Disease area, infectious disease: Yes (lowers risk) · Disease area
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
- 6 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- single (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 8 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 90 (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
- 247 (typical: 32)
- Sponsor's past termination rate
- 10.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 260 (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
- 7630 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1414 (typical: 412.5)
- Drug's FAERS reports marked serious
- 91.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 24.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, digestive
- Drugs matched to FDA substances
- vancomycin
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 to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD) NCT02218372 · started 2015 · scored riskier than 18% of active trials completed
- Study of a Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection NCT00772343 · started 2009 · scored riskier than 20% of active trials completed
- Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff NCT03110133 · started 2017 · scored riskier than 68% of active trials completed
- Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea NCT01987895 · started 2014 · scored riskier than 18% of active trials completed
- Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea NCT01983683 · started 2013 · scored riskier than 20% 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.