Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy
Model scores of the 29,894 trials active now.
Model score 20% 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 14% of the time (493 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 2014-05-09, after 2013-01-23 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 2014-05-09. 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: may applycriteria mayprotocol defineddefined inclusionblind placebo
Phrases that lowered it: investigatehas historystudy willhypersensitivity toangioedema -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 13.2% (raises risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 312 (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 6.7% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Blinding: double (raises risk) · Design
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Sponsor's past trials: 469 (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Number of arms: 2 (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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- 75 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 469 (typical: 32)
- Sponsor's past termination rate
- 13.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 312 (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
- 7748 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1937 (typical: 412.5)
- Drug's FAERS reports marked serious
- 85.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, immunology, dermatology
- Drugs matched to FDA substances
- omalizumab
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 of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients NCT02329223 · started 2014 · scored riskier than 17% of active trials completed
- Cold Urticaria Treatment With Xolair NCT01580592 · started 2012 · scored riskier than 45% of active trials completed
- Efficacy and Safety Study of Omalizumab (Xolair®) to Treat Chronic Urticaria NCT01713725 · started 2012 · scored riskier than 31% of active trials completed
- Mode of Action Study of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Fail to Respond to Antihistamine Treatment NCT01599637 · started 2012 · scored riskier than 81% of active trials completed
- Prospective Double-blind Placebo-controlled Study of the Effect of Xolair (Omalizumab) in Chronic Urticaria Patients NCT01803763 · started 2012 · scored riskier than 15% 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.