Study of RAD001 for Treatment of NF2-related Vestibular Schwannoma
Model scores of the 29,894 trials active now.
Model score 25% for any early termination, 13% 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 in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2024-02-06, after 2015-07-01 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 2024-02-06. 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: radiationto determinetumorssquamous cellpatients
Phrases that lowered it: drugmonotherapythe studysinglehypersensitivity to -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Drug's FAERS reports with a death: 29.6% (raises risk) · Drug's FDA history
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Sponsor's past termination rate: 8.8% (raises risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Design: single group (raises risk) · Design
-
Maximum age: 65 (lowers risk) · Who can join
-
Disease area, neurology: Yes (raises risk) · Disease area
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Minimum age: 16 (raises risk) · Who can join
-
Number of arms: 1 (raises risk) · Design
-
Collaborators: 1 (raises risk) · Design
-
Responsible party: sponsor (lowers risk) · Design
-
Drug's FAERS reports marked serious: 91.5% (raises risk) · Drug's FDA history
-
Drug's FAERS reports before start: 11497 (raises 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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 16 (typical: 18)
- Maximum age
- 65 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 80 (typical: 32)
- Sponsor's past termination rate
- 8.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 16 (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
- 11497 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3238 (typical: 412.5)
- Drug's FAERS reports marked serious
- 91.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 29.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, neurology
- Drugs matched to FDA substances
- everolimus
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
- Efficacy and Safety Study of RAD001 in the Growth of the Vestibular Schwannoma(s) in Neurofibromatosis 2 (NF2) Patients NCT01490476 · started 2012 · scored riskier than 90% of active trials completed
- Efficacy and Safety of RAD001 in Treating Plexiform Neurofibromas (PN) Associated With Neurofibromatosis (NF1) NCT01365468 · started 2012 · scored riskier than 96% of active trials terminated
- Use of RAD001 as Monotherapy in the Treatment of Neurofibromatosis 1 Related Internal Plexiform Neurofibromas NCT01412892 · started 2011 · scored riskier than 97% of active trials completed
- Study of Axitinib in Patients With Neurofibromatosis Type 2 and Progressive Vestibular Schwannomas NCT02129647 · started 2014 · scored riskier than 95% of active trials completed
- RAMSETE: RAD001 in Advanced and Metastatic Silent Neuro-endocrine Tumors in Europe NCT00688623 · started 2009 · scored riskier than 40% 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.