Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants
Model scores of the 29,894 trials active now.
Model score 11% 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 17% of the time (213 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2018-04-25, after 2016-10-09 start.
Reason given by the sponsor: “business”
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 2018-04-25. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: pretermbirthplacebo controlledassessearly
Phrases that lowered it: the effecteffect ofand safetyevaluate theefficacy and -
Sponsor's past termination rate: 100% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Phase: 3 (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
-
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
-
Blinding: quadruple (lowers risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Minimum age: 0 (lowers risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Sponsor's past trials: 1 (lowers risk) · Sponsor's track record
-
Number of arms: 3 (lowers risk) · Design
-
Maximum age: 0.01 (raises risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 0 (lowers risk) · Sponsor's track record
-
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
- 3 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: 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
- 0 (typical: 18)
- Maximum age
- 0.01 (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
- 1 (typical: 32)
- Sponsor's past termination rate
- 100% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- digestive, metabolic, urogenital
- 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
- Safety and Efficacy Study in Infant With SBS NCT02865122 · started 2017 · scored riskier than 68% of active trials terminated
- STP206 for the Prevention of Necrotizing Enterocolitis (NEC) NCT01954017 · started 2014 · scored riskier than 18% of active trials completed
- IBP-9414 for the Prevention of Necrotizing Enterocolitis NCT02472769 · started 2016 · scored riskier than 17% of active trials completed
- Oral Formulation of Insulin for Preterm Infants NCT01093638 · started 2010 · scored riskier than 4% of active trials terminated
- Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants NCT02325791 · started 2015 · scored riskier than 4% 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.