Albumin Administration in Cirrhotic Patients With Bacterial Infection and a Systemic Inflammatory Response Syndrome Unrelated to Spontaneous Bacterial Peritonitis
Model scores of the 29,894 trials active now.
Model score 15% for any early termination, 8% 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 (313 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 2012-06-30, after 2008-12-31 start.
Reason given by the sponsor: “safety”
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 2012-06-30. 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
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: childfailuresurvivalcarcinomacirrhosis
Phrases that lowered it: effect ofthe effecttermadministrationrandomized -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Drug's FAERS reports with a death: 38.9% (raises risk) · Drug's FDA history
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Phase: 3 (lowers risk) · Design
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Design: parallel (raises risk) · Design
-
Primary purpose: treatment (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 3 (raises risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 94.7% (raises risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Number of arms: 2 (raises 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
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (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
- academic or other
- Sponsor's past trials
- 3 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 3 (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
- 470 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 117 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 38.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, urogenital
- Drugs matched to FDA substances
- albumin human
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
- Effect of Albumin Administration on Vasopressor Duration in Resolving Septic Shock NCT02716597 · started 2016 · scored riskier than 76% of active trials terminated
- Lactated Ringer Versus Albumin in Early Sepsis Therapy NCT01337934 · started 2013 · scored riskier than 52% of active trials completed
- Two Strategies of Primary Prophylaxis of Spontaneous Bacterial Peritonitis in Severe Cirrhotic Patients With Ascites NCT03069131 · started 2018 · scored riskier than 77% of active trials completed
- Albumin Replacement Therapy in Septic Shock NCT03869385 · started 2019 · scored riskier than 45% of active trials terminated
- Fluid Resuscitation in Early Septic Shock NCT00819416 · started 2009 · scored riskier than 37% 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.