Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis
Model scores of the 29,894 trials active now.
Model score 19% 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 (1,463 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 2020-07-08, after 2009-08-05 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 2020-07-08. 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: No (raises risk) · Who can join
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: evaluatesubjectliverfemalelabel study
Phrases that lowered it: protocolmgkeylong termsubjects -
Sponsor's past termination rate: 16.1% (raises risk) · Sponsor's track record
-
Phase: 3 (lowers risk) · Design
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
-
Has a data monitoring committee: No (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 352 (raises risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
-
Design: not given (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Sponsor's past trials: 608 (raises risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
-
Blinding: none (lowers risk) · Design
-
Disease area, neurology: No (lowers risk) · Disease area
-
Maximum age: not given (lowers risk) · Who can join
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
- not given (typical: 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
- 608 (typical: 32)
- Sponsor's past termination rate
- 16.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 352 (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
- none of the 14 tracked areas
- Drugs matched to FDA substances
- tafamidis
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
- An Extension of Study Fx-005 Evaluating Long-Term Safety And Clinical Outcomes Of Fx-1006A In Patients With Transthyretin Amyloid Polyneuropathy NCT00791492 · started 2008 · scored riskier than 74% of active trials completed
- Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy NCT02791230 · started 2016 · scored riskier than 38% of active trials completed
- Safety And Efficacy Evaluation Of Fx-1006a In Patients With V122i Or Wild-Type Transthyretin (TTR) Amyloid Cardiomyopathy NCT00935012 · started 2009 · scored riskier than 61% of active trials completed
- The Effects of Fx-1006A on Transthyretin Stabilization and Clinical Outcome Measures in Patients With Non-V30M Transthyretin Amyloidosis NCT00630864 · started 2008 · scored riskier than 82% of active trials completed
- Safety, Efficacy and Pharmacokinetics of Doxycycline Plus Tauroursodeoxycholic Acid in Transthyretin Amyloidosis NCT01171859 · started 2010 · scored riskier than 50% 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.