Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma
Model scores of the 29,894 trials active now.
Model score 12% 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 20% of the time (607 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 2012-10-31, after 2010-10-31 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 2012-10-31. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: metastaticpatientpriorto determineadequate
Phrases that lowered it: safetymethotrexatemtxoutpatientfemales -
Sponsor's past termination rate: 3.0% (lowers risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Drug's FAERS reports marked serious: 60.9% (lowers risk) · Drug's FDA history
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Disease area, cancer: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 10.1% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 47 (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Drug's FAERS reports before start: 48433 (lowers risk) · Drug's FDA history
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Sponsor's past trials: 66 (lowers risk) · Sponsor's track record
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Maximum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 9104 (lowers risk) · Drug's FDA history
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Number of arms: 1 (raises risk) · Design
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
- 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
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 6 (typical: 18)
- Maximum age
- 18 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 66 (typical: 32)
- Sponsor's past termination rate
- 3.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 47 (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
- 48433 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 9104 (typical: 412.5)
- Drug's FAERS reports marked serious
- 60.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- methotrexate
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
- Investigation of [6R] 5,10-methylenetetrahydrofolate (Arfolitixorin) as Rescue Therapy for Osteosarcoma Patients Treated With HDMTX. NCT01987102 · started 2013 · scored riskier than 67% of active trials completed
- Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia NCT03964259 · started 2019 · scored riskier than 82% of active trials completed
- High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma NCT00634322 · started 2008 · scored riskier than 17% of active trials terminated
- A Phase I/II Study to Investigate the Use of VORAXAZE™ As Intended Intervention in Patients with CNSL NCT04841434 · started 2021 · scored riskier than 87% of active trials completed
- To Compare the Efficacy of the Addition of Methotrexate (MTX) to Current Standard Acute Graft-versus-host Disease (GVHD) First-line Treatment With Corticosteroids NCT03371667 · started 2018 · scored riskier than 54% 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.