Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children
Model scores of the 29,894 trials active now.
Model score 8% 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 10% of the time (1,463 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 2018-09-04, after 2014-04-30 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 2018-09-04. 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) (lowers risk) · Wording
Phrases that raised it: multipleperformanceused inor plannedscore
Phrases that lowered it: and safetyefficacy andsafety ofchildrenkg -
Sponsor's past termination rate: 21.3% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports marked serious: 18.6% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 1.1% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 10 (lowers risk) · Sponsor's track record
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Maximum age: 17 (lowers risk) · Who can join
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Blinding: double (raises risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Primary purpose: treatment (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
- 3 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 2 (typical: 18)
- Maximum age
- 17 (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
- 75 (typical: 32)
- Sponsor's past termination rate
- 21.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 10 (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
- 17413 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3100 (typical: 412.5)
- Drug's FAERS reports marked serious
- 18.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 1.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- abobotulinumtoxina, botulinum toxin type a
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
- Dysport® Adult Upper Limb Spasticity NCT01313299 · started 2011 · scored riskier than 27% of active trials completed
- Dysport® Pediatric Lower Limb Spasticity Study NCT01249417 · started 2011 · scored riskier than 39% of active trials completed
- Dysport® Adult Lower Limb Spasticity Study NCT01249404 · started 2011 · scored riskier than 43% of active trials completed
- Dysport® Adult Upper Limb Spasticity Extension Study NCT01313312 · started 2011 · scored riskier than 58% of active trials completed
- Dysport® Adult Lower Limb Spasticity Follow-on Study NCT01251367 · started 2011 · scored riskier than 27% 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.