Early Signs of Efficacy Study With Riociguat in Adult Homozygous Delta F508 Cystic Fibrosis Patients
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 4% 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 (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
Terminated on 2017-09-22, after 2014-09-30 start.
Reason given by the sponsor: “other”
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 2017-09-22. 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: screeningtolerabilitytransplantationkgmonths prior
Phrases that lowered it: patientscombinationused inefficacypatient -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 6.3% (lowers risk) · Sponsor's track record
-
Phase: 2 (raises risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
Drug's FAERS reports marked serious: 55.0% (lowers risk) · Drug's FDA history
-
Design: parallel (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 105 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 8.3% (lowers risk) · Drug's FDA history
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Collaborators: 1 (raises risk) · Design
-
Sponsor's past trials: 524 (raises risk) · Sponsor's track record
-
Keywords listed: 6 (lowers 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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- 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
- industry (typical: academic or other)
- Sponsor's past trials
- 524 (typical: 32)
- Sponsor's past termination rate
- 6.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 105 (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
- 545 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 524 (typical: 412.5)
- Drug's FAERS reports marked serious
- 55.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory, digestive
- Drugs matched to FDA substances
- riociguat
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
- 28 Day Repeat Dose in Cystic Fibrosis Patients NCT00903201 · started 2009 · scored riskier than 27% of active trials completed
- SD Cystic Fibrosis Study NCT00605761 · started 2008 · scored riskier than 6% of active trials completed
- A Study to Evaluate Safety, PK and PD of FDL169 in Cystic Fibrosis Subjects NCT03093714 · started 2017 · scored riskier than 14% of active trials completed
- Inhaled Vancomycin Tolerability, Safety and Pharmacokinetics NCT01537666 · started 2011 · scored riskier than 3% of active trials completed
- A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis NCT02951182 · started 2016 · scored riskier than 10% 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.