Study to Test the Hypothesis of Non-inferior Efficacy and Safety of Ferrum Lek® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewable Tablets (Lek d.d., Slovenia), as Compared With MALTOFER® (Vifor S.A., Switzerland), in Subjects With Mild and Moderate Iron Deficiency Anemia.
Model scores of the 29,894 trials active now.
Model score 10% 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 16% of the time (927 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2020-06-18, after 2019-06-27 start.
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 2020-06-18. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: subjectirontherapydiabetesmarrow
Phrases that lowered it: and safetyefficacy andsafety ofdiseasesblood -
Disease area, cancer: Yes (raises risk) · Disease area
-
Phase: 3 (lowers risk) · Design
-
Sponsor's past termination rate: 5.1% (lowers risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports with a death: 8.9% (lowers risk) · Drug's FDA history
-
Has a data monitoring committee: No (lowers risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 66.6% (lowers risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Sponsor's past trials: 99 (lowers risk) · Sponsor's track record
-
Disease area, neurology: No (lowers risk) · Disease area
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Responsible party: sponsor (lowers risk) · Design
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
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 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
- 99 (typical: 32)
- Sponsor's past termination rate
- 5.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 4 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 47180 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 7041 (typical: 412.5)
- Drug's FAERS reports marked serious
- 66.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, immunology, hematology
- Drugs matched to FDA substances
- hydroxide, iron
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
- Evaluate the Safety and Efficacy of Ferric Maltol Oral Suspension vs. Ferrous Sulfate Oral Liquid in Children and Adolescents Aged 2 to 17 Years With Iron-deficiency Anaemia, With a Single Arm Study in Infants Aged 1 Month to Less Than 2 Years NCT05126901 · started 2021 · scored riskier than 18% of active trials completed
- Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease NCT02968368 · started 2016 · scored riskier than 59% 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
- Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency Anaemia NCT06080555 · started 2023 · scored riskier than 6% of active trials completed
- Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) NCT00994318 · started 2009 · scored riskier than 36% 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.