Injection Site Pain Botulinum Toxin Reconstituted in NS With and Without Sodium Bicarbonate
Model scores of the 29,894 trials active now.
Model score 4% for any early termination, 1% 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 (53 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2020-08-09, after 2019-11-09 start.
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 2020-08-09. 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: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: onsetpainrandomized doublemoderatetissue
Phrases that lowered it: femalepatientspatient whogoodinvestigate -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Minimum age: 25 (lowers risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Blinding: triple (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports with a death: 10.1% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 76.6% (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 216216 (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 3 (lowers risk) · Sponsor's track record
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
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 25 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: 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
- 0 (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
- 216216 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 33817 (typical: 412.5)
- Drug's FAERS reports marked serious
- 76.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- bicarbonate
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
- Botulinum Toxin A Single Blind Split-Face Randomized Pilot Study NCT02907268 · started 2013 · scored riskier than 6% of active trials completed
- Safety and Efficacy of the Use of Botox on Acne NCT00765375 · started 2008 · scored riskier than 6% of active trials terminated
- Clinical Trial To Evaluate ANT-1207 In Subjects With Acne NCT01293552 · started 2011 · scored riskier than 7% of active trials completed
- Comparison of Two Botulinum Toxins Type A on Forehead Wrinkles NCT01014871 · started 2009 · scored riskier than 10% of active trials completed
- Trial Comparing Two Commercial Formulations of Botulinum Toxin Type A in the Treatment of Spasticity NCT00819065 · started 2009 · scored riskier than 11% 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.