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A Phase 3, Long-Term Safety Study of Subcutaneous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME -Anemia Management With Epoetin

NCT01628120 on ClinicalTrials.gov Phase 3 Pfizer (industry) Started 2012-05-31 Completed
Riskier than 90% of active trials
this trial: 25% 0% 36%

Model scores of the 29,894 trials active now.

Model score 25% 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 (181 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 2015-02-13, after 2012-05-31 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

0% 21% 43% 64% 85% 0123456 yr completed 74% terminated 21%

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2015-02-13. 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

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
1 (typical: 2)
Allocation
not applicable (typical: randomized)
Design
single group (typical: 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
80 (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
1104 (typical: 32)
Sponsor's past termination rate
16.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years
317 (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
10275 (typical: 2148)
Drug's FAERS reports in the prior 12 months
1330 (typical: 412.5)
Drug's FAERS reports marked serious
76.4% (typical: 85.6%)
Drug's FAERS reports with a death
20.0% (typical: 15.9%)

Disease area and drugs

Disease areas
urogenital
Drugs matched to FDA substances
epoetin

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

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.