Methylnaltrexone for Opioid-induced Constipation in Cancer Patients
Model scores of the 29,894 trials active now.
Model score 31% for any early termination, 27% 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
Completed on 2013-12-31, after 2009-10-31 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 2013-12-31. 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: entryulncanceropioiddl
Phrases that lowered it: severethe efficacyinduceddays beforethe previous -
Phase: 2 (raises risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Disease area, cancer: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 31.4% (raises risk) · Drug's FDA history
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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's past termination rate: 7.1% (lowers risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports marked serious: 97.1% (raises risk) · Drug's FDA history
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Primary purpose: supportive care (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 15 (lowers risk) · Sponsor's track record
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Number of arms: 1 (raises risk) · Design
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Sponsor's past trials: 14 (raises risk) · Sponsor's track record
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Keywords listed: 5 (lowers risk) · Design
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Collaborators: 0 (raises risk) · Design
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Allocation: not applicable (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
- supportive care (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 5 (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
- 14 (typical: 32)
- Sponsor's past termination rate
- 7.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 15 (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
- 35 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 29 (typical: 412.5)
- Drug's FAERS reports marked serious
- 97.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 31.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, psychiatry
- Drugs matched to FDA substances
- methylnaltrexone
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
- Study Evaluating the Efficacy and Safety of Subcutaneous Methylnaltrexone (MOA-728) for the Treatment of Opioid-Induced-Constipation NCT00936884 · started 2009 · scored riskier than 27% of active trials completed
- A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain NCT01186770 · started 2010 · scored riskier than 18% of active trials completed
- Naloxegol in Cancer Opioid-Induced Constipation NCT02745353 · started 2016 · scored riskier than 97% of active trials terminated
- Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain NCT01384292 · started 2011 · scored riskier than 26% of active trials terminated
- A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy NCT01443403 · started 2011 · scored riskier than 69% 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.