Effectiveness of onaBoNT-A vs Oral Tamsulosin in Men With BPH and LUTS
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 14% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 18% of the time (785 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 2019-09-30, after 2012-06-01 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 2019-09-30. 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
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: prostatecancercellpsabiopsy
Phrases that lowered it: volunteersmultiple sclerosisvisittractmale -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Design: parallel (raises risk) · Design
-
Blinding: triple (raises risk) · Design
-
Minimum age: 50 (lowers risk) · Who can join
-
Sponsor's past termination rate: 7.1% (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 105 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 12.2% (lowers risk) · Drug's FDA history
-
Primary purpose: treatment (raises risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
-
Sponsor type: government (raises risk) · Sponsor's track record
-
Responsible party: sponsor (lowers risk) · Design
-
Maximum age: not given (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 81.2% (lowers risk) · Drug's FDA history
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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 50 (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
- government (typical: academic or other)
- Sponsor's past trials
- 84 (typical: 32)
- Sponsor's past termination rate
- 7.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 105 (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
- 5943 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1985 (typical: 412.5)
- Drug's FAERS reports marked serious
- 81.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- tamsulosin
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
- Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter NCT03423979 · started 2017 · scored riskier than 70% of active trials completed
- Trial of the Safety and Efficacy of Ozarelix in Participants With Benign Prostatic Hyperplasia (BPH) NCT00743184 · started 2008 · scored riskier than 34% of active trials terminated
- Study to Compare the Efficacy and Safety of Combination Treatment With Dutasteride and Tamsulosin With Tamsulosin Monotherapy, in Men With Moderate to Severe Benign Prostatic Hyperplasia NCT02058368 · started 2014 · scored riskier than 24% of active trials completed
- Effects and Safety of OPK-88004 Doses in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) NCT03297398 · started 2018 · scored riskier than 84% of active trials terminated
- Efficacy and Safety of a Single TRUS-guided Intraprostatic Injection of NX-1207 in Patients With LUTS Due to BPH NCT02003742 · started 2013 · scored riskier than 18% of active trials terminated
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.