Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia
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 15% of the time (734 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2016-11-30, after 2015-06-30 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 2016-11-30. 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) (lowers risk) · Wording
Phrases that raised it: subjectcelldiseaserandomizationlast dose
Phrases that lowered it: evaluate theto evaluatepharmacokineticinvestigatorand safety -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 9.7% (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Phase: 3 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 14.8% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 82 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 370 (lowers risk) · Sponsor's track record
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Maximum age: 25 (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 84.4% (lowers risk) · Drug's FDA history
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Blinding: double (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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 1
Who can join
- Minimum age
- 10 (typical: 18)
- Maximum age
- 25 (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
- 370 (typical: 32)
- Sponsor's past termination rate
- 9.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 82 (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
- 2508 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 372 (typical: 412.5)
- Drug's FAERS reports marked serious
- 84.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 14.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, metabolic
- Drugs matched to FDA substances
- interferon, interferon gamma1b
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
- Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia Study NCT02593773 · started 2015 · scored riskier than 52% of active trials completed
- Interferon Gamma-1b in Friedreich Ataxia (FRDA) NCT01965327 · started 2013 · scored riskier than 62% of active trials completed
- Long-Term Safety Extension Study of ACTIMMUNE® (Interferon γ-1b) in Children and Young Adults With Friedreich's Ataxia NCT02797080 · started 2016 · scored riskier than 31% of active trials completed
- A Phase IIa Trial to Test Safety and Efficacy Interferon Gamma Treatment in Elevating Frataxin Levels in FRDA Patients NCT02035020 · started 2013 · scored riskier than 60% of active trials completed
- Open Trail of γIFN for Friedreich Ataxia NCT03888664 · started 2016 · scored riskier than 28% 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.