A Study to Evaluate Pain, Tolerability, Safety, and Usability of a Single Self-administered Etrolizumab by Auto-injector in Healthy Participants

NCT02629744 on ClinicalTrials.gov Phase 1 Genentech, Inc. (industry) Started 2015-12-31 Completed

Riskier than 2% of active trials

Model scores of the 29,894 trials active now.

Model score 3% 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 5% of the time (4,470 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2016-06-30, after 2015-12-31 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 2016-06-30. 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

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: tolerabilitycancereligiblenonrecurrent
Phrases that lowered it: participantshealthyparticipantsingleopen label
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Primary purpose: not given (lowers risk) · Design
Phase: 1 (lowers risk) · Design
Has a data monitoring committee: not given (lowers risk) · Design
Design: single group (raises risk) · Design
Trials the sponsor started in the prior 2 years: 43 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
Blinding: none (lowers risk) · Design
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
Sponsor's past termination rate: 7.2% (lowers risk) · Sponsor's track record

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: 1 (typical: 2)
Allocation: not applicable (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: not given (typical: treatment)
Blinding: none
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 65 (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 222 (typical: 32)
Sponsor's past termination rate: 7.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 43 (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: etrolizumab

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

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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.