Safety Study in Adolescent and Adult Patients With Asthma
Model scores of the 29,894 trials active now.
Model score 9% 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 6% of the time (528 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 2012-07-31, after 2011-11-30 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 2012-07-31. 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
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: therapyconcurrentsubjectspatients withplacebo
Phrases that lowered it: screeningasthmasafetyrespiratorymale -
Sponsor's past termination rate: 44.4% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Blinding: triple (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 16.2% (lowers risk) · Drug's FDA history
-
Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
-
Maximum age: 75 (raises risk) · Who can join
-
Disease area, neurology: No (lowers risk) · Disease area
-
Disease area, respiratory: Yes (raises risk) · Disease area
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Number of arms: 3 (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 8 (lowers risk) · Sponsor's track record
-
Sponsor's past trials: 9 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 85.8% (raises 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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 12 (typical: 18)
- Maximum age
- 75 (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
- 9 (typical: 32)
- Sponsor's past termination rate
- 44.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 8 (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
- 8923 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2361 (typical: 412.5)
- Drug's FAERS reports marked serious
- 85.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 16.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory, immunology
- Drugs matched to FDA substances
- epinephrine
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
- Evaluation of Efficacy and Safety for Single Dose of E004 in Children With Asthma NCT01737905 · started 2012 · scored riskier than 4% of active trials completed
- Evaluation of Efficacy and Safety of E004 in Children With Asthma NCT01460511 · started 2011 · scored riskier than 8% of active trials completed
- Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma NCT03706079 · started 2019 · scored riskier than 16% of active trials completed
- Randomized, Placebo/Active Crossover Dose-ranging Study for Safety and Efficacy in Asthma Patients. NCT01025648 · started 2009 · scored riskier than 4% of active trials terminated
- A Phase IIa Repeat Dose AXP1275 vs Placebo Cross-over Trial With Pulmonary Allergen Challenge in Adults With Asthma NCT01890161 · started 2013 · scored riskier than 4% 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.