Phase III Study to Investigate the Safety and Efficacy of Fermagate and Lanthanum Carbonate
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 9% of the time (803 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
Terminated on 2011-07-31, after 2009-07-31 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 2011-07-31. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: mg dlmmolserumreceivingentry
Phrases that lowered it: the investigatoropinioninvestigatesafetybody -
Sponsor's past termination rate: 33.3% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Has a data monitoring committee: Yes (raises risk) · Design
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 8.6% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Responsible party: not given (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Maximum age: not given (lowers risk) · Who can join
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- not given (typical: 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
- 3 (typical: 32)
- Sponsor's past termination rate
- 33.3% (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
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 3517 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 949 (typical: 412.5)
- Drug's FAERS reports marked serious
- 70.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, urogenital
- Drugs matched to FDA substances
- iron, lanthanum carbonate
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
- Phase III Study to Investigate the Safety and Efficacy of Fermagate and Sevelamer Hydrochloride NCT00844662 · started 2009 · scored riskier than 28% of active trials terminated
- PA21 Safety and Efficacy in Adult Chinese Subjects NCT03644264 · started 2018 · scored riskier than 16% of active trials completed
- Safety, Pharmacokinetics and Efficacy of MBX 2109 in Patients With Hypoparathyroidism NCT06465108 · started 2024 · scored riskier than 24% of active trials completed
- Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) NCT03299244 · started 2018 · scored riskier than 37% of active trials completed
- Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Participants With Hypoparathyroidism NCT02781844 · started 2017 · scored riskier than 5% 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.