A Prospective, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Non-Anaemic Patients Undergoing Elective or Sub-Acute Coronary Artery Bypass Graft, Valve Replacement or a Combination Thereof
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (139 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 2012-01-31 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
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: acutewomenintravenousnonprior to
Phrases that lowered it: multipleclinical trialscreening visitperiodproducts -
Has a data monitoring committee: Yes (raises risk) · Design
-
Design: parallel (raises risk) · Design
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Phase: 3 (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
-
Blinding: double (raises risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
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Collaborators: 1 (raises risk) · Design
-
Sponsor's past trials: 2 (raises risk) · Sponsor's track record
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Number of arms: 2 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 5 (raises risk) · Sponsor's track record
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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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 2 (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
- 2 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 5 (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
- hematology
- Drugs matched to FDA substances
- iron isomaltoside
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
- A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Iron-deficient Blood Donors NCT01895231 · started 2013 · scored riskier than 8% of active trials completed
- IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose NCT02130063 · started 2014 · scored riskier than 12% of active trials completed
- Postoperative i.v. Iron Substitution in Patients With Diagnosed Iron Deficiency NCT03817957 · started 2018 · scored riskier than 35% of active trials completed
- Iron Isomaltoside 1000 (Monofer®) in Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia NCT01102413 · started 2010 · scored riskier than 13% of active trials completed
- Preoperative Intravenous Iron to Treat Anaemia in Major Surgery NCT01692418 · started 2014 · scored riskier than 53% 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.