Anidulafungin PK in Infants and Toddlers
Model scores of the 29,894 trials active now.
Model score 13% for any early termination, 3% 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 (340 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 2010-06-30, after 2008-01-31 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 2010-06-30. 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
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: hourstime ofconditionkgthe time
Phrases that lowered it: pharmacokineticopen labelpkparticipation incriteria patients -
Responsible party: sponsor investigator (raises risk) · Design
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Design: single group (raises risk) · Design
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports with a death: 7.7% (lowers risk) · Drug's FDA history
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Number of arms: 1 (raises risk) · Design
-
Minimum age: not given (lowers risk) · Who can join
-
Maximum age: 2 (raises risk) · Who can join
-
Drug's FAERS reports before start: 26 (lowers 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
- 1 (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
- not given (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- 2 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (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
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 26 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 18 (typical: 412.5)
- Drug's FAERS reports marked serious
- 88.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease
- Drugs matched to FDA substances
- anidulafungin
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
- Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis NCT00761267 · started 2009 · scored riskier than 36% of active trials completed
- Pharmacokinetics (PK) of Antistaphylococcal Antibiotics in Infants (NICHD-2012-02-Staph Trio) NCT01728363 · started 2013 · scored riskier than 13% of active trials completed
- Anidulafungin in Patients With Hematologic Malignancies NCT01053884 · started 2009 · scored riskier than 45% of active trials terminated
- A Study of Intravenous Oseltamivir [Tamiflu] in Infants With Influenza NCT01053663 · started 2011 · scored riskier than 11% of active trials terminated
- Pharmacokinetics (PK) Study of a Fluconazole Loading Dose in Infants and Toddlers NCT00797420 · started 2008 · scored riskier than 9% 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.