Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® .
Model scores of the 29,894 trials active now.
Model score 9% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 9% of the time (803 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-11-01, after 2021-03-31 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 2024-11-01. 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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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
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Drug's FAERS reports marked serious: 52.1% (lowers risk) · Drug's FDA history
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: cellpatientcarcinomabonesitu
Phrases that lowered it: and safetyhealthyevaluate thediseasesscreening -
Design: parallel (raises risk) · Design
-
Drug's FAERS reports with a death: 13.9% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 50 (lowers risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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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: quadruple (lowers risk) · Design
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Maximum age: 85 (lowers risk) · Who can join
-
Drug's FAERS reports before start: 154664 (lowers risk) · Drug's FDA history
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
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 50 (typical: 18)
- Maximum age
- 85 (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 3 (typical: 32)
- Sponsor's past termination rate
- 0% (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
- 154664 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 10836 (typical: 412.5)
- Drug's FAERS reports marked serious
- 52.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 13.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, musculoskeletal
- Drugs matched to FDA substances
- denosumab
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
- Denosumab China Phase III Study NCT02014467 · started 2014 · scored riskier than 19% of active trials completed
- A Phase 3 Study to Compare Biosimilar Denosumab With Prolia® NCT05405725 · started 2022 · scored riskier than 23% of active trials completed
- A Six-month Phase 2 Study of Oral hPTH(1-34) (EBP05) in Postmenopausal Women With Low Bone Mass NCT04003467 · started 2019 · scored riskier than 19% of active trials completed
- A Study on Efficacy, Safety and Immunogenicity of 9MW0311 in Postmenopausal Women With Osteoporosis NCT06804590 · started 2024 · scored riskier than 23% of active trials completed
- A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture NCT05352516 · started 2022 · scored riskier than 12% 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.