Study of Nalbuphine ER in Participants With Hepatic Impairment
Model scores of the 29,894 trials active now.
Model score 4% 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 5% of the time (4,470 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2020-02-05, after 2019-06-12 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2020-02-05. 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
-
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: multiplefunctionertolerabilityillness
Phrases that lowered it: healthyparticipantspharmacokineticeffectmoderate -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Drug's FAERS reports with a death: 6.1% (lowers risk) · Drug's FDA history
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Maximum age: 80 (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 81.0% (lowers risk) · Drug's FDA history
-
Disease area, neurology: No (lowers risk) · Disease area
-
Disease area, psychiatry: No (lowers 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
- 1 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 80 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: 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
- 2 (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
- 790 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 152 (typical: 412.5)
- Drug's FAERS reports marked serious
- 81.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- nalbuphine
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 Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Brensocatib in Participants With Normal Hepatic Function and Participants With Hepatic Impairment NCT05517525 · started 2022 · scored riskier than 2% of active trials completed
- Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function NCT01923870 · started 2013 · scored riskier than 7% of active trials completed
- Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Mild Hepatic Impairment Compared to Participants With Normal Hepatic Function NCT05283915 · started 2022 · scored riskier than 8% of active trials completed
- Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects NCT03681457 · started 2018 · scored riskier than 5% of active trials completed
- A Phase 1 Study to Compare the PK and Safety of Naproxcinod in Hepatic Impaired Patients and Matching Healthy Subjects NCT00621881 · started 2008 · scored riskier than 3% 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.