A Study to Evaluate P1101 in Japanese PV Patients
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (927 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-07-26, after 2023-10-17 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 2024-07-26. 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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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: carcinomaulntherapydlpatient
Phrases that lowered it: singlescreeningsafetymalejapanese -
Phase: 3 (lowers risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 9.4% (lowers risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports before start: 644964 (lowers risk) · Drug's FDA history
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Number of arms: 1 (raises risk) · Design
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Drug's FAERS reports marked serious: 72.9% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 2 (raises risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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Drug's FAERS reports in the prior 12 months: 34288 (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
- 3 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (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
- 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
- 2 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 644964 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 34288 (typical: 412.5)
- Drug's FAERS reports marked serious
- 72.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, hematology
- Drugs matched to FDA substances
- aspirin, ropeginterferon alfa2b
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
- Efficacy and Safety of P1101 in Polycythemia Vera Patients for Whom the Standard of Treatment is Difficult to Apply NCT04182100 · started 2019 · scored riskier than 26% of active trials completed
- Study With SAR302503 in Patients With Polycythemia Vera or Essential Thrombocythemia NCT01420783 · started 2011 · scored riskier than 89% of active trials completed
- Pegylated Interferon Alpha-2b Versus Hydroxyurea in Polycythemia Vera NCT01949805 · started 2013 · scored riskier than 42% of active trials completed
- Safety Study of Pegylated Interferon Alpha 2b to Treat Polycythemia Vera NCT01193699 · started 2010 · scored riskier than 85% of active trials completed
- Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea in Polycythemia Vera (PV) and Essential Thrombocythemia (ET) NCT01259856 · started 2011 · scored riskier than 97% 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.