A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore:
Model scores of the 29,894 trials active now.
Model score 6% 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 2012-05-31, after 2011-03-31 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 2012-05-31. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: priorto determinedefinedor relevanttreated
Phrases that lowered it: copdpulmonarychronic obstructivefev1bronchodilator -
Phase: 3 (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 330 (raises risk) · Sponsor's track record
-
Minimum age: 40 (lowers risk) · Who can join
-
Sponsor's past termination rate: 7.8% (lowers risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports with a death: 9.2% (lowers risk) · Drug's FDA history
-
Sponsor's past trials: 939 (raises risk) · Sponsor's track record
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Disease area, neurology: No (lowers risk) · Disease area
-
Maximum age: 80 (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 67.8% (lowers risk) · Drug's FDA history
-
Primary purpose: treatment (raises risk) · Design
-
Blinding: double (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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: 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
- 40 (typical: 18)
- Maximum age
- 80 (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
- 939 (typical: 32)
- Sponsor's past termination rate
- 7.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 330 (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
- 27629 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5821 (typical: 412.5)
- Drug's FAERS reports marked serious
- 67.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory
- Drugs matched to FDA substances
- albuterol, roflumilast
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 Randomized Double-blind Clinical Study Evaluated the Safety, Pharmacokinetic and Pharmacodynamic Characteristics of Roflumilast in COPD Patients NCT02671942 · started 2016 · scored riskier than 16% of active trials terminated
- Effect of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease NCT01473758 · started 2012 · scored riskier than 31% of active trials terminated
- Evaluation of 611 in Chinese Adults With Moderate to Severe Chronic Obstructive Pulmonary Disease NCT06099652 · started 2023 · scored riskier than 8% of active trials completed
- Study to Evaluate the Safety and Efficacy of Formoterol in a Daily Dose of 18 µg (9 µg Twice Daily) in Japanese Chronic Obstructive Pulmonary Disease (COPD) Patients NCT01047553 · started 2009 · scored riskier than 7% of active trials completed
- Japan Long-term Safety for Tiotropium Plus Olodaterol NCT01536262 · started 2012 · 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.