A Novel Regimen to Prevent Malaria and STI in Pregnant Women With HIV
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 10% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (331 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-01-01, after 2018-03-07 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 2022-01-01. 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: acutepurpose ofthe purposewomenpregnancy
Phrases that lowered it: malariareceivetrial isefficacy andadverse -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 11.4% (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Primary purpose: prevention (lowers risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Drug's FAERS reports with a death: 11.7% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Trials the sponsor started in the prior 2 years: 87 (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Sponsor's past trials: 281 (lowers risk) · Sponsor's track record
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Number of arms: 2 (raises risk) · Design
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Drug's FAERS reports before start: 109731 (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 79.8% (lowers risk) · Drug's FDA history
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Responsible party: principal investigator (lowers risk) · Design
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Drug's FAERS reports in the prior 12 months: 17124 (lowers risk) · Drug's FDA history
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Maximum age: 55 (lowers risk) · Who can join
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Collaborators: 0 (raises risk) · Design
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Minimum age: 16 (raises risk) · Who can join
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
- prevention (typical: treatment)
- Blinding
- quadruple (typical: 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
- 16 (typical: 18)
- Maximum age
- 55 (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 281 (typical: 32)
- Sponsor's past termination rate
- 11.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 87 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 109731 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 17124 (typical: 412.5)
- Drug's FAERS reports marked serious
- 79.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, urogenital
- Drugs matched to FDA substances
- azithromycin, sulfamethoxazole, trimethoprim
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
- Prevention of Malaria in HIV-uninfected Pregnant Women and Infants NCT02793622 · started 2016 · scored riskier than 8% of active trials completed
- Establishing Effectiveness of Daily Co-trimoxazole Prophylaxis For Prevention of Malaria in Pregnancy NCT01053325 · started 2010 · scored riskier than 34% of active trials completed
- Improving PRegnancy Outcomes With PReVEntive Therapy in Africa-2 (IMPROVE-2) NCT04158713 · started 2019 · scored riskier than 4% of active trials completed
- Reducing the Burden of Malaria in HIV-Infected Pregnant Women and Their HIV-Exposed Children (PROMOTE-BC2) NCT02282293 · started 2014 · scored riskier than 6% of active trials completed
- Prevention of Pregnancy-associated Malaria in HIV-infected Women: Cotrimoxazole Prophylaxis Versus Mefloquine NCT00970879 · started 2009 · scored riskier than 10% 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.