Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib
Model scores of the 29,894 trials active now.
Model score 34% 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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-10-31, after 2018-10-09 start.
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 2022-10-31. 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: metastaticcellsher2adjuvantstage
Phrases that lowered it: aminotransferasereceiveproductsulnopen -
Phase: 2 (raises risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 12.7% (raises risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 161 (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, dermatology: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 13.2% (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 before start: 90579 (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 72.4% (lowers risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 17093 (lowers risk) · Drug's FDA history
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Collaborators: 1 (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Sponsor's past trials: 699 (lowers risk) · Sponsor's track record
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Blinding: none (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
- 2
- Allocation
- non randomized (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
- 1 (typical: 0)
- Keywords listed
- 2 (typical: 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
- 699 (typical: 32)
- Sponsor's past termination rate
- 12.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 161 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 7 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 90579 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 17093 (typical: 412.5)
- Drug's FAERS reports marked serious
- 72.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 13.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- atropine, atropine diphenoxylate, crofelemer, diphenoxylate, loperamide, neratinib, trastuzumab
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
- Phase1 of Neratinib+Trastuzumab, Pertuzumab, Paclitaxel in Patients With Advanced Solid Tumors/HER2+ NCT02593708 · started 2015 · scored riskier than 36% of active trials terminated
- Combination of Weekly Paclitaxel With Neratinib and Trastuzumab in Women With Metastatic HER2-positive Breast Cancer NCT01423123 · started 2011 · scored riskier than 91% of active trials completed
- Neratinib in Treating Older Patients With Stage IV HER2-Positive Breast Cancer NCT02673398 · started 2016 · scored riskier than 98% of active trials completed
- Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer NCT01827267 · started 2013 · scored riskier than 84% of active trials completed
- Capecitabine, Cyclophosphamide, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With HER2-Positive Metastatic Breast Cancer NCT01873833 · started 2013 · scored riskier than 78% of active trials terminated
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.