Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors
Model scores of the 29,894 trials active now.
Model score 8% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 16% of the time (3,151 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2020-06-30, after 2015-09-30 start.
Reason given by the sponsor: “enrollment”
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 2020-06-30. 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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Design: factorial (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 8.9% (raises risk) · Sponsor's track record
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Collaborators: 7 (lowers risk) · Design
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Phase: 3 (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: cellcancerplaceboprostateable
Phrases that lowered it: pulmonaryaminotransferasescreeninglimiteffect of -
Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 61.2% (lowers risk) · Drug's FDA history
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Drug's FAERS reports with a death: 7.2% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Trials the sponsor started in the prior 2 years: 93 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports before start: 122121 (lowers risk) · Drug's FDA history
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Number of arms: 4 (lowers risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Drug's FAERS reports in the prior 12 months: 30695 (lowers risk) · Drug's FDA history
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Sponsor's past trials: 158 (lowers 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
- 4 (typical: 2)
- Allocation
- randomized
- Design
- factorial (typical: parallel)
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 7 (typical: 0)
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 65 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 158 (typical: 32)
- Sponsor's past termination rate
- 8.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 93 (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
- 122121 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 30695 (typical: 412.5)
- Drug's FAERS reports marked serious
- 61.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- endocrine
- Drugs matched to FDA substances
- cholecalciferol, testosterone
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
- Zurich Disability Prevention Trial NCT01017354 · started 2010 · scored riskier than 26% of active trials completed
- DO-HEALTH / Vitamin D3 - Omega3 - Home Exercise - Healthy Ageing and Longevity Trial NCT01745263 · started 2012 · scored riskier than 6% of active trials completed
- Effect of Vitamin D Treatment on Fatigue NCT02022475 · started 2013 · scored riskier than 5% of active trials completed
- A Study of LY2495655 in Older Participants Undergoing Elective Total Hip Replacement NCT01369511 · started 2011 · scored riskier than 65% of active trials completed
- Starting a Testosterone and Exercise Program After Hip Injury NCT02938923 · started 2019 · scored riskier than 59% 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.