Efficacy and Safety of Obinutuzumab Preemptive Treatment at the Time of the Molecular Relapse
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 16% 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 2020-01-31, after 2018-05-14 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 2020-01-31. 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
-
Sponsor's past termination rate: 50% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: celllymphomawomencarcinomastage
Phrases that lowered it: linehcvand safetydiseasesupper -
Phase: 2 (raises risk) · Design
-
Disease area, cancer: Yes (raises risk) · Disease area
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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
-
Drug's FAERS reports with a death: 12.5% (lowers risk) · Drug's FDA history
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Minimum 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 marked serious: 85.4% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Maximum age: 65 (lowers risk) · Who can join
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Number of arms: 1 (raises risk) · Design
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Drug's FAERS reports before start: 3253 (raises risk) · Drug's FDA history
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Collaborators: 1 (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Responsible party: sponsor (lowers 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
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 1
Who can join
- Minimum age
- 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
- 2 (typical: 32)
- Sponsor's past termination rate
- 50% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 3253 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1161 (typical: 412.5)
- Drug's FAERS reports marked serious
- 85.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, immunology, hematology
- Drugs matched to FDA substances
- obinutuzumab
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 of Upfront and Maintenance Obinutuzumab in Mantle Cell Lymphoma Treated by DHAP and MRD Driven Maintenance NCT02896582 · started 2016 · scored riskier than 64% of active trials completed
- Bendamustine + Obinutuzumab Induction With Obinutuzumab Maintenance in Untreated Mantle Cell Lymphoma NCT03311126 · started 2017 · scored riskier than 98% of active trials terminated
- Bendamustine/Lenalidomide/Rituximab: Combination as a Second-Line Therapy for 1st Relapsed-Refractory MCL NCT01737177 · started 2012 · scored riskier than 52% of active trials completed
- Ofatumumab With or Without Bendamustine for Patients With Mantle Cell Lymphoma Ineligible for Autologous Stem Cell Transplant NCT01437709 · started 2011 · scored riskier than 64% of active trials completed
- A Trial of Obinutuzumab,GDC-0199 Plus Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma Patients NCT02558816 · started 2015 · scored riskier than 91% 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.