Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG)
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 24% of the time (231 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-10-17, after 2018-06-07 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 2022-10-17. 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: subjectcancersubjects withhearttherapy
Phrases that lowered it: participantsinvestigatorpatients whomgcriteria patients -
Sponsor's past termination rate: 18.3% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1 (lowers risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 166 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 18.9% (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 73.0% (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 455748 (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Design: sequential (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: government (raises risk) · Sponsor's track record
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Drug's FAERS reports in the prior 12 months: 92538 (lowers risk) · Drug's FDA history
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Number of arms: 4 (lowers risk) · Design
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Drugs with FDA adverse-event history: 4 (lowers risk) · Drug's FDA history
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
- 4 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: 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
- government (typical: academic or other)
- Sponsor's past trials
- 1174 (typical: 32)
- Sponsor's past termination rate
- 18.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 166 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 455748 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 92538 (typical: 412.5)
- Drug's FAERS reports marked serious
- 73.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 18.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, urogenital
- Drugs matched to FDA substances
- acetaminophen, diphenhydramine, durvalumab, histamine
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
- Phase 2 Durvalumab (Medi4736) for Bacillus Calmette-Guérin (BCG) Refactory Urothelial Carcinoma in Situ of the Bladder NCT02901548 · started 2017 · scored riskier than 94% of active trials terminated
- Durvalumab And Radiation Therapy Followed by Adjuvant Durvalumab in Patients With Urothelial Cancer (T2-4 N0-2 M0) of the Bladder NCT02891161 · started 2016 · scored riskier than 98% of active trials terminated
- Durvalumab and Standard Chemotherapy Before Surgery in Treating Patients With Variant Histology Bladder Cancer NCT03912818 · started 2019 · scored riskier than 58% of active trials terminated
- Vicinium Treatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCG NCT02449239 · started 2015 · scored riskier than 97% of active trials completed
- A Feasibility Study of Durvalumab +/- Oleclumab as Neoadjuvant Therapy for Muscle-invasive Bladder Cancer (BLASST-2) NCT03773666 · started 2019 · scored riskier than 85% 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.