Trial of Low-Dose Methotrexate and I 131 Tositumomab for Previously Untreated, Advanced-Stage, Follicular Lymphoma
Model scores of the 29,894 trials active now.
Model score 30% for any early termination, 18% 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 2016-06-30, after 2011-07-31 start.
Reason given by the sponsor: “business”
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 2016-06-30. 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
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: patients mustradiationcancerfunctionof study
Phrases that lowered it: lymphomamethotrexatefollicularbloodto participate -
Sponsor's past termination rate: 28.0% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Drug's FAERS reports marked serious: 60.0% (lowers risk) · Drug's FDA history
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Disease area, cancer: Yes (raises risk) · Disease area
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Has a data monitoring committee: Yes (raises risk) · Design
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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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Drug's FAERS reports in the prior 12 months: 12185 (lowers risk) · Drug's FDA history
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Drug's FAERS reports with a death: 9.7% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports before start: 59129 (lowers risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
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Number of arms: 1 (raises risk) · Design
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Drugs with FDA adverse-event history: 3 (lowers risk) · Drug's FDA history
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Blinding: none (raises risk) · Design
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Collaborators: 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
- 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
- 1
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 50 (typical: 32)
- Sponsor's past termination rate
- 28.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 9 (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
- 59129 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 12185 (typical: 412.5)
- Drug's FAERS reports marked serious
- 60.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, immunology, hematology
- Drugs matched to FDA substances
- iodine, methotrexate, tositumomab, tositumomab i131
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
- Bendamustine and Rituximab Followed by 90-yttrium (Y) Ibritumomab Tiuxetan for Untreated Follicular Lymphoma NCT01234766 · started 2010 · scored riskier than 99% of active trials completed
- A Phase 1/2 Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma NCT01796171 · started 2012 · scored riskier than 78% of active trials completed
- Rituximab, Combination Chemotherapy, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed Follicular Non-Hodgkin Lymphoma NCT00637832 · started 2008 · scored riskier than 64% of active trials terminated
- Rituximab With or Without Yttrium Y-90 Ibritumomab Tiuxetan in Treating Patients With Untreated Follicular Lymphoma NCT02320292 · started 2015 · scored riskier than 59% of active trials terminated
- Monoclonal Antibody CT-011 in Combination With Rituximab in Patients With Relapsed Follicular Lymphoma NCT00904722 · started 2010 · scored riskier than 99% 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.