An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 2% 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 (369 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
Terminated on 2014-03-31, after 2013-03-01 start.
Reason given by the sponsor: “efficacy”
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 2014-03-31. 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
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: chronicsletransplantsubject hastolerability
Phrases that lowered it: and safetyefficacyclinicalinvestigational productsafety of -
Sponsor's past trials: 1726 (raises risk) · Sponsor's track record
-
Sponsor's past termination rate: 4.8% (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Number of arms: 5 (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Phase: 2 (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 342 (raises risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
-
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
-
Blinding: double (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Collaborators: 0 (raises risk) · Design
-
Disease area, neurology: No (lowers risk) · Disease area
-
Disease area, dermatology: Yes (raises risk) · Disease area
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
- 5 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (typical: 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
- 1726 (typical: 32)
- Sponsor's past termination rate
- 4.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 342 (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
- immunology, dermatology
- 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 I Study of GSK1550188 in Japanese Subjects With Systemic Lupus Erythematosus (SLE) NCT01381536 · started 2010 · scored riskier than 9% of active trials completed
- Belimumab Phase I Study in Chinese Subjects With Systemic Lupus Erythematosus NCT02880852 · started 2017 · scored riskier than 28% of active trials completed
- A Study to Evaluate the Safety, Tolerability, and PK Profile of Single and Multiple Doses TJ202 in Patient With Systemic Lupus Erythematosus NCT05140824 · started 2021 · scored riskier than 47% of active trials terminated
- A Study of AMG 557 in Adults With Systemic Lupus Erythematosus NCT00774943 · started 2008 · scored riskier than 39% of active trials completed
- A Study of NKTR-358 (LY3471851) in Participants With Systemic Lupus Erythematosus (SLE) NCT03556007 · started 2018 · scored riskier than 43% 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.