Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (331 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
Terminated on 2013-12-30, after 2011-09-30 start.
Reason given by the sponsor: “enrollment”
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 2013-12-30. 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) (raises risk) · Wording
Phrases that raised it: transplantcellallogeneiccombinationlong term
Phrases that lowered it: respiratorytractpulmonarydrugsclinical -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Primary purpose: prevention (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports with a death: 9.8% (lowers risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 70.9% (lowers risk) · Drug's FDA history
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Responsible party: principal investigator (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 6 (raises risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
-
Sponsor's past trials: 5 (raises risk) · Sponsor's track record
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Number of arms: 2 (raises risk) · Design
-
Blinding: none (raises risk) · Design
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Has a data monitoring committee: No (raises risk) · Design
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Drugs with FDA adverse-event history: 6 (lowers risk) · Drug's FDA history
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Collaborators: 1 (raises risk) · Design
-
Disease area, respiratory: Yes (raises risk) · Disease area
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
- prevention (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 5 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 6 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 6 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 92986 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 24441 (typical: 412.5)
- Drug's FAERS reports marked serious
- 70.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, respiratory
- Drugs matched to FDA substances
- azithromycin, budesonide, budesonide formoterol, formoterol, montelukast, prednisone
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
- Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans Syndrome NCT01287078 · started 2011 · scored riskier than 60% of active trials completed
- Bilateral Orthotopic Lung Transplant - Bone Marrow Transplant NCT03330795 · started 2017 · scored riskier than 91% of active trials completed
- Extension Study (Extended Access) of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans NCT01273207 · started 2012 · scored riskier than 50% of active trials completed
- Ruxolitinib for Early Lung Dysfunction After Hematopoietic Stem Cell Transplant NCT04908735 · started 2021 · scored riskier than 82% of active trials terminated
- Efficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 ≥10% From Pre Transplantation NCT04655508 · started 2021 · scored riskier than 36% 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.