Dose Escalation Study of SQ109 in Healthy Adult Volunteers
Model scores of the 29,894 trials active now.
Model score 4% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 7% of the time (106 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 2009-11-30, after 2009-04-30 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 2009-11-30. 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) (lowers risk) · Wording
Phrases that raised it: subject hasthe subjectsafety tolerabilityplaceboventricular
Phrases that lowered it: healthyvolunteersdayequal toor equal -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 3.8% (lowers risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Responsible party: not given (raises risk) · Design
-
Sponsor's past trials: 741 (raises risk) · Sponsor's track record
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Blinding: double (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 87 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 3 (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: no FAERS history (raises 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
- 1 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- 45 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 741 (typical: 32)
- Sponsor's past termination rate
- 3.8% (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
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- none matched
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
- Phase IC Study of Safety and PK of SQ109 300mg Daily NCT01358162 · started 2010 · scored riskier than 6% of active trials completed
- First Time in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Food of Single Assending Doses of GSK1482160. NCT00849134 · started 2008 · scored riskier than 8% of active trials completed
- A Study to Evaluate the Safety, Tolerability and Amount of EI-1071 in Blood in Healthy Volunteers NCT04238364 · started 2019 · scored riskier than 4% of active trials completed
- A Safety and Pharmacokinetic (PK) Study of GSK2982772 in Healthy Subjects NCT03305419 · started 2017 · scored riskier than 8% of active trials completed
- To Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P17 NCT04295356 · started 2019 · scored riskier than 3% 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.