Study With SAR302503 in Patients With Polycythemia Vera or Essential Thrombocythemia
Model scores of the 29,894 trials active now.
Model score 25% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 22% of the time (1,598 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 2014-05-31, after 2011-10-31 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 2014-05-31. 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) (raises risk) · Wording
Phrases that raised it: carcinomapatients mustheartpriorcell
Phrases that lowered it: visitthe efficacydaysafety ofmg -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Sponsor's past termination rate: 9.9% (raises risk) · Sponsor's track record
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Design: parallel (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 99 (lowers risk) · Sponsor's track record
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Number of arms: 4 (lowers risk) · Design
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
-
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
-
Primary purpose: treatment (raises risk) · Design
-
Sponsor's past trials: 304 (lowers risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Maximum age: not given (raises risk) · Who can join
-
Collaborators: 0 (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
- 2
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (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
- 304 (typical: 32)
- Sponsor's past termination rate
- 9.9%
- Trials the sponsor started in the prior 2 years
- 99 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, hematology
- Drugs matched to FDA substances
- fedratinib
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 Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Idasanutlin Monotherapy in Participants With Hydroxyurea-Resistant/Intolerant Polycythemia Vera NCT03287245 · started 2018 · scored riskier than 66% of active trials terminated
- Phase 2 Study of SAR302503 in Patients With Myelofibrosis NCT01420770 · started 2011 · scored riskier than 92% of active trials completed
- A Two-part Study to Assess the Safety and Preliminary Efficacy of Givinostat in Patients With Polycythemia Vera NCT01901432 · started 2013 · scored riskier than 95% of active trials completed
- A Study to Evaluate P1101 in Japanese PV Patients NCT06002490 · started 2023 · scored riskier than 23% of active trials completed
- Open Label Study of Single Agent Oral RG7388 in Patients With Polycythemia Vera and Essential Thrombocythemia NCT02407080 · started 2015 · scored riskier than 87% 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.