Efficacy and Safety Study of P-Gemox vs.EPOCH as First-line Chemotherapy to Treat NK/T-cell Lymphoma With Early Stage
Model scores of the 29,894 trials active now.
Model score 10% for any early termination, 4% 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 in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2017-06-30, after 2015-05-31 start.
Reason given by the sponsor: “other”
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 2017-06-30. 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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Sponsor's past termination rate: 1.4% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: chemotherapystagecellgemcitabineoxaliplatin
Phrases that lowered it: efficacy andand safetysafety ofthe efficacycell lymphoma -
Disease area, cancer: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 100 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: parallel (raises risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 20.7% (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 235839 (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Maximum age: 70 (lowers risk) · Who can join
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Drug's FAERS reports marked serious: 86.3% (lowers risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 45770 (lowers 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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- 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
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 70 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 72 (typical: 32)
- Sponsor's past termination rate
- 1.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 100 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 8 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 235839 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 45770 (typical: 412.5)
- Drug's FAERS reports marked serious
- 86.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 20.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- cyclophosphamide, doxorubicin, etoposide, gemcitabine, oxaliplatin, pegaspargase, prednisone, vincristine
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
- P-Gemox Regimen as First-line Chemotherapy in NK/T Lymphoma Patiens NCT02533323 · started 2012 · scored riskier than 27% of active trials terminated
- Sandwich Chemotherapy With Radiotherapy in Newly Diagnosed, Stage IE to IIE, ENKTL NCT02520479 · started 2013 · scored riskier than 33% of active trials terminated
- Radiotherapy Combined With GDP Chemotherapy in Stage I/II Extranodal Natural Killer/T-cell Lymphoma NCT02276248 · started 2010 · scored riskier than 52% of active trials completed
- Evaluating the Effectiveness of Decitabine With Gemcitabine, Oxaliplatin for Relapsed/Refractory Peripheral T-cell Lymphoma NCT06941688 · started 2020 · scored riskier than 41% of active trials terminated
- B-MAD Chemotherapy in Newly-diagnosed Extranodal NK/ T-cell Lymphoma NCT03246750 · started 2019 · scored riskier than 56% 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.