Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder
Model scores of the 29,894 trials active now.
Model score 23% 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 12% of the time (422 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2020-07-31, after 2018-12-21 start.
Reason given by the sponsor: “enrollment”
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 2020-07-31. 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
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: the subjectriskextensionincreasemsec
Phrases that lowered it: open labelparticipantfemalethe trialmg -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 10.1% (raises risk) · Sponsor's track record
-
Phase: 3 (lowers risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Design: single group (raises risk) · Design
-
Disease area, psychiatry: Yes (raises risk) · Disease area
-
Maximum age: 17 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 82.0% (lowers risk) · Drug's FDA history
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Drug's FAERS reports with a death: 19.3% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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Collaborators: 0 (raises risk) · Design
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Minimum age: 10 (raises 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
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 10 (typical: 18)
- Maximum age
- 17 (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
- 336 (typical: 32)
- Sponsor's past termination rate
- 10.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 3452 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 520 (typical: 412.5)
- Drug's FAERS reports marked serious
- 82.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 19.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- psychiatry
- Drugs matched to FDA substances
- ziprasidone
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
- Lurasidone Pediatric Bipolar Study NCT02046369 · started 2014 · scored riskier than 20% of active trials completed
- Lamotrigine Phase III Study in Bipolar I Disorder NCT01602510 · started 2012 · scored riskier than 41% of active trials completed
- PEARL Schizophrenia Maintenance NCT01435928 · started 2011 · scored riskier than 51% of active trials completed
- Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features. NCT01122927 · started 2010 · scored riskier than 12% of active trials terminated
- Pediatric Schizophrenia Efficacy and Safety Study NCT01911429 · started 2013 · scored riskier than 11% 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.