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Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)

NCT03988634 on ClinicalTrials.gov Phase 3 Novartis Pharmaceuticals (industry) Started 2019-06-29 Completed
Riskier than 84% of active trials
this trial: 23% 0% 36%

Model scores of the 29,894 trials active now.

Model score 23% for any early termination, 5% 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 (1,463 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2022-12-14, after 2019-06-29 start.

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

0% 18% 36% 55% 73% 0123456 yr completed 63% terminated 22%

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2022-12-14. 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
2
Allocation
randomized
Design
parallel
Primary purpose
treatment
Blinding
double (typical: none)
Has a data monitoring committee
Yes (typical: 56% yes)
Responsible party
sponsor
Collaborators
0
Keywords listed
8 (typical: 1)

Who can join

Minimum age
18
Maximum age
99 (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
1237 (typical: 32)
Sponsor's past termination rate
15.0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years
162 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history
3 (typical: 1)
Drug has FAERS history
Yes (typical: 64% yes)
Drug's FAERS reports before start
162251 (typical: 2148)
Drug's FAERS reports in the prior 12 months
38305 (typical: 412.5)
Drug's FAERS reports marked serious
64.9% (typical: 85.6%)
Drug's FAERS reports with a death
11.2% (typical: 15.9%)

Disease area and drugs

Disease areas
none of the 14 tracked areas
Drugs matched to FDA substances
sacubitril, sacubitril valsartan, valsartan

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.