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FMISO-PET in Brain Tumors and SCS Effect

NCT01868906 on ClinicalTrials.gov Phase 2 Bernardino Clavo, MD, PhD (academic or other) Started 2013-06-30 Terminated
Riskier than 78% of active trials
this trial: 22% 0% 36%

Model scores of the 29,894 trials active now.

Model score 22% for any early termination, 12% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (3,728 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 2017-09-17, after 2013-06-30 start.

Reason given by the sponsor: “other”

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% 10% 20% 30% 40% 0123456 yr completed 34% terminated 33%

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2017-09-17. 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
2
Number of arms
2
Allocation
non randomized (typical: randomized)
Design
parallel
Primary purpose
diagnostic (typical: treatment)
Blinding
none
Has a data monitoring committee
No (typical: 56% yes)
Responsible party
sponsor investigator (typical: sponsor)
Collaborators
6 (typical: 0)
Keywords listed
12 (typical: 1)

Who can join

Minimum age
18
Maximum age
75 (typical: 71)
Sex
all
Accepts healthy volunteers
No (typical: 9% yes)

Sponsor's track record

Sponsor type
academic or other
Sponsor's past trials
0 (typical: 32)
Sponsor's past termination rate
no earlier finished trials (typical: 9.9%)
Trials the sponsor started in the prior 2 years
0 (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
4435 (typical: 2148)
Drug's FAERS reports in the prior 12 months
815 (typical: 412.5)
Drug's FAERS reports marked serious
93.3% (typical: 85.6%)
Drug's FAERS reports with a death
25.7% (typical: 15.9%)

Disease area and drugs

Disease areas
cancer, neurology
Drugs matched to FDA substances
temozolomide

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.