Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity
Model scores of the 29,894 trials active now.
Model score 13% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (1,198 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 2017-01-31, after 2014-08-31 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 2017-01-31. 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
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 3.7% (lowers risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: infantsenrollmentchildrenbraindefined as
Phrases that lowered it: efficacydrugsdifferentzone20 -
Design: parallel (raises risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Responsible party: principal investigator (lowers risk) · Design
-
Drug's FAERS reports with a death: 25.4% (raises risk) · Drug's FDA history
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Minimum age: not given (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 97.0% (raises risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
-
Sponsor type: academic or other (raises 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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- not given (typical: 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
- 27 (typical: 32)
- Sponsor's past termination rate
- 3.7% (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
- 12061 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2991 (typical: 412.5)
- Drug's FAERS reports marked serious
- 97.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 25.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- ranibizumab
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
- RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity NCT02375971 · started 2015 · scored riskier than 74% of active trials completed
- Intravitreal Ranibizumab Injection for Aggressive Versus Type 1 Prethreshold Retinopathy of Prematurity NCT05701124 · started 2020 · scored riskier than 20% of active trials completed
- A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROP NCT04634604 · started 2022 · scored riskier than 34% of active trials terminated
- Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy NCT04004208 · started 2019 · scored riskier than 39% of active trials completed
- Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity NCT04101721 · started 2019 · scored riskier than 71% 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.