Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
Model scores of the 29,894 trials active now.
Model score 9% 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 21% of the time (143 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 2013-09-30, after 2010-01-31 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 2013-09-30. 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
-
Sponsor's past termination rate: 26.3% (raises risk) · Sponsor's track record
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Collaborators: 3 (lowers risk) · Design
-
Phase: 2 (raises risk) · Design
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: infantshoursbirthplacebo controlledfailure
Phrases that lowered it: kgpharmacokineticsweightmgpharmacokinetic -
Has a data monitoring committee: Yes (raises risk) · Design
-
Primary purpose: prevention (lowers risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Number of arms: 4 (lowers risk) · Design
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Minimum age: not given (raises risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 2 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 70% (lowers risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
-
Disease area, neurology: No (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
- 2
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 3 (typical: 0)
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 19 (typical: 32)
- Sponsor's past termination rate
- 26.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 2 (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
- 10 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2 (typical: 412.5)
- Drug's FAERS reports marked serious
- 70% (typical: 85.6%)
- Drug's FAERS reports with a death
- 20% (typical: 15.9%)
Disease area and drugs
- Disease areas
- respiratory, urogenital
- Drugs matched to FDA substances
- inositol
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
- Inositol to Reduce Retinopathy of Prematurity NCT01954082 · started 2014 · scored riskier than 70% of active trials terminated
- STP206 for the Prevention of Necrotizing Enterocolitis (NEC) NCT01954017 · started 2014 · scored riskier than 18% of active trials completed
- IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity NCT01096784 · started 2010 · scored riskier than 34% of active trials completed
- IBP-9414 for the Prevention of Necrotizing Enterocolitis NCT02472769 · started 2016 · scored riskier than 17% of active trials completed
- Early Blood Pressure Management in Extremely Premature Infants NCT00874393 · started 2009 · scored riskier than 35% 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.