Japanese Phase 1 Multiple Ascending Dose Study
Model scores of the 29,894 trials active now.
Model score 8% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 6% of the time (816 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 2012-09-30, after 2012-03-31 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 2012-09-30. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Minimum age: 20 (lowers risk) · Who can join
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Sponsor's past termination rate: 9.7% (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Phase: 1 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 100 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: multipleplacebo controlledbmspatientpatients
Phrases that lowered it: healthyjapaneseevaluatesafetyprogram -
Disease area, cancer: No (lowers risk) · Disease area
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Sponsor's past trials: 321 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 5 (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, psychiatry: No (lowers risk) · Disease area
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Responsible party: sponsor (lowers risk) · Design
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Disease area, metabolic: Yes (lowers risk) · Disease area
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
- 1 (typical: 2)
- Number of arms
- 5 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: 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
- 20 (typical: 18)
- Maximum age
- 65 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 321 (typical: 32)
- Sponsor's past termination rate
- 9.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 100 (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
- metabolic, endocrine
- Drugs matched to FDA substances
- none matched
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
- Multiple Ascending Dose Study of BMS-820132 in Patients With Type 2 Diabetes NCT01290575 · started 2011 · scored riskier than 13% of active trials completed
- Safety Study of BMS-823778 in Subjects With Type 2 Diabetes NCT01111955 · started 2010 · scored riskier than 37% of active trials completed
- Safety Study to Evaluate BMS-767778 in Healthy Subjects and Subjects With Type 2 Diabetes Mellitus (T2DM) NCT00707590 · started 2008 · scored riskier than 40% of active trials terminated
- Single Ascending Dose Study of BMS-820132 in Patients With Type 2 Diabetes NCT01105429 · started 2010 · scored riskier than 32% of active trials completed
- Safety Study of BMS-903452 in Healthy Subjects (Panel 1-7) & Relative Bioavailability of the Crystalline and Amorphous Forms of BMS-903452 [Panels 4, 6, 11 & 12(Part A)], and Subjects With Type 2 Diabetes Mellitus (Part B) NCT01240980 · started 2010 · scored riskier than 17% 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.