Efficacy and Safety Study of JNJ-32729463 for Treating Complicated Skin and Skin Structure Infections Compared to Linezolid (Zyvox)
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 3% 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 2011-01-31, after 2010-06-30 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 2011-01-31. 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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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: skinsubject hasother protocolmay applycriteria may
Phrases that lowered it: tolerabilitydiseasessafetyallergicefficacy -
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Responsible party: not given (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports with a death: 20.9% (raises risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 94.4% (raises risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Disease area, dermatology: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Drug's FAERS reports in the prior 12 months: 437 (raises risk) · Drug's FDA history
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Maximum age: 70 (lowers 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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 11 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 70 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 2800 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 437 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 20.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, dermatology
- Drugs matched to FDA substances
- linezolid
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
- Study the Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI) NCT00865280 · started 2009 · scored riskier than 21% of active trials terminated
- Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections NCT00633152 · started 2008 · scored riskier than 61% of active trials completed
- MRX-I Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection NCT02269319 · started 2015 · scored riskier than 27% of active trials completed
- Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure Infections NCT00761215 · started 2008 · scored riskier than 18% of active trials completed
- Comparative Study of NXL103 Versus Linezolid in Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI) NCT00949130 · started 2009 · scored riskier than 9% 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.