Study of the Efficacy and Safety of Pasireotide s.c. +/- Cabergoline in Patients With Cushing's Disease
Model scores of the 29,894 trials active now.
Model score 21% for any early termination, 7% 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
Terminated on 2019-09-04, after 2014-03-06 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 2019-09-04. 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: ulnuncontrolledchildwomenphase ii
Phrases that lowered it: trialscreeningand safetymaleefficacy and -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Sponsor's past termination rate: 11.9% (raises risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, neurology: Yes (raises risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Sponsor's past trials: 623 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 6.8% (lowers risk) · Drug's FDA history
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Blinding: none (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 301 (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 92.9% (raises 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
- 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
- 9 (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
- 623 (typical: 32)
- Sponsor's past termination rate
- 11.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 301 (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
- 1484 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 209 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, neurology, endocrine
- Drugs matched to FDA substances
- cabergoline, pasireotide
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 Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease. NCT01582061 · started 2011 · scored riskier than 70% of active trials completed
- Pasireotide LAR Therapy of Silent Corticotroph Pituitary Tumors NCT02749227 · started 2017 · scored riskier than 91% of active trials terminated
- Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues NCT02354508 · started 2015 · scored riskier than 41% of active trials completed
- Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease NCT01374906 · started 2011 · scored riskier than 45% of active trials completed
- Treatment Plan for an Individual Patient With Pasireotide for Hyperinsulinemic Hypoglycemia NCT03103009 · started 2017 · scored riskier than 39% 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.