An Extension Clinical Study of BCD-148 for the Treatment of Patients With PNH Previously Treated in Clinical Study No. BCD-148-2/NOCTURN
Model scores of the 29,894 trials active now.
Model score 7% 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 10% of the time (139 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-11-02, after 2020-04-13 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 2022-11-02. 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: patientlimitedpostmenopausalsurgicalin women
Phrases that lowered it: alcoholclinical studyparticipantsthe clinicalin clinical -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 2.6% (lowers risk) · Sponsor's track record
-
Phase: 3 (lowers risk) · Design
-
Drug's FAERS reports marked serious: 59.2% (lowers risk) · Drug's FDA history
-
Drug's FAERS reports with a death: 9.6% (lowers risk) · Drug's FDA history
-
Design: single group (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Has a data monitoring committee: No (lowers risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 11 (raises risk) · Sponsor's track record
-
Disease area, neurology: No (lowers risk) · Disease area
-
Number of arms: 1 (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
- 1 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- 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
- 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
- 38 (typical: 32)
- Sponsor's past termination rate
- 2.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 11 (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
- 39418 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5164 (typical: 412.5)
- Drug's FAERS reports marked serious
- 59.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- hematology
- Drugs matched to FDA substances
- eculizumab
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
- Long-term Safety of BCX9930 in Participants With Paroxysmal Nocturnal Hemoglobinuria NCT05741346 · started 2023 · scored riskier than 76% of active trials terminated
- A Long-Term Safety Study of BCX9930 in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) NCT04702568 · started 2020 · scored riskier than 51% of active trials terminated
- First-in-Human Study of BCX9930 in Healthy Volunteers and Patients With PNH NCT04330534 · started 2020 · scored riskier than 9% of active trials completed
- Dose Escalation of BCX10013 in Participants with Paroxysmal Nocturnal Hemoglobinuria (PNH) NCT06100900 · started 2023 · scored riskier than 58% of active trials completed
- Clinical Trial of BCD-148 and Soliris® for the Treatment of Patients With Paroxysmal Nocturnal Hemoglobinuria NCT04060264 · started 2019 · scored riskier than 14% 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.