A Multicenter, Open-label, Single Dose Study of the Safety and Efficacy of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Focal Upper Limb Spasticity
Model scores of the 29,894 trials active now.
Model score 10% 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 15% of the time (734 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 2012-03-31, after 2010-09-30 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 2012-03-31. 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) (lowers risk) · Wording
Phrases that raised it: strokegreatersubjectconcurrentqtc
Phrases that lowered it: subjectsevaluate theto evaluatesafetyefficacy -
Phase: 3 (lowers risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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Has a data monitoring committee: not given (lowers risk) · Design
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Drug's FAERS reports marked serious: 32.6% (lowers risk) · Drug's FDA history
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Drug's FAERS reports with a death: 2.1% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 439 (raises risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Sponsor's past termination rate: 4.4% (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Sponsor's past trials: 1248 (raises risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Maximum age: 76 (raises risk) · Who can join
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Drug's FAERS reports in the prior 12 months: 4046 (lowers risk) · Drug's FDA history
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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 76 (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
- 1248 (typical: 32)
- Sponsor's past termination rate
- 4.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 439 (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
- 5398 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4046 (typical: 412.5)
- Drug's FAERS reports marked serious
- 32.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, musculoskeletal
- Drugs matched to FDA substances
- 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
- A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Upper Limb Spasticity NCT01153815 · started 2010 · scored riskier than 11% of active trials completed
- A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 in Subjects With Post-stroke Upper Limb Spasticity NCT03261167 · started 2017 · scored riskier than 14% of active trials completed
- A Study to Evaluate the Botulinum Toxin Type A for Injection(HengLi®) in Subjects With Post-stroke Upper Limb Spasticity NCT02280083 · started 2014 · scored riskier than 15% of active trials completed
- Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity NCT04815967 · started 2021 · scored riskier than 23% of active trials terminated
- Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity NCT04099667 · started 2019 · scored riskier than 23% of active trials terminated
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.