Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)

Model scores of the 29,894 trials active now.

Model score 26% 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.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2018-02-09. 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.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: other protocolprotocol definedlong termextensiondefined inclusion
  Phrases that lowered it: participantstrialto evaluateparticipationmg
• Sponsor's past termination rate: 29.6% (raises risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 2 (raises risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Design: parallel (raises risk) · Design
• Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
• Blinding: double (raises risk) · Design
• Disease area, dermatology: Yes (raises risk) · Disease area
• Trials the sponsor started in the prior 2 years: 11 (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Number of arms: 3 (lowers risk) · Design
• Maximum age: not given (lowers risk) · Who can join
• Sponsor's past trials: 54 (lowers risk) · Sponsor's track record
• Disease area, neurology: No (lowers risk) · Disease area
• Drug's FAERS reports before start: 1 (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.

• Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE) NCT00624338 · started 2008 · scored riskier than 49% of active trials completed
• Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus NCT01972568 · started 2013 · scored riskier than 30% of active trials completed
• An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus NCT03407482 · started 2018 · scored riskier than 89% of active trials terminated
• A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321 NCT01305746 · started 2011 · scored riskier than 98% of active trials completed
• On Open-Label Study in Participants With Systemic Lupus Erythematosus NCT01488708 · started 2012 · scored riskier than 69% of active trials terminated

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.