Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 11% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (3,728 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2017-03-15, after 2016-06-07 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 2017-03-15. 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) (raises risk) · Wording
Phrases that raised it: kidneybreast cancerchemotherapystagetransplantation
Phrases that lowered it: efficacygroupuppercooperativeevaluate the -
Sponsor's past termination rate: 3.8% (lowers risk) · Sponsor's track record
-
Phase: 2 (raises risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 152 (lowers risk) · Sponsor's track record
-
Sponsor's past trials: 312 (lowers risk) · Sponsor's track record
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Design: single group (raises risk) · Design
-
Minimum age: 19 (lowers risk) · Who can join
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 23.9% (raises risk) · Drug's FDA history
-
Number of arms: 1 (raises risk) · Design
-
Maximum age: 65 (lowers risk) · Who can join
-
Drug's FAERS reports before start: 103347 (lowers risk) · Drug's FDA history
-
Primary purpose: treatment (raises risk) · Design
-
Blinding: none (raises risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
-
Disease area, dermatology: Yes (raises risk) · Disease area
-
Collaborators: 0 (raises risk) · Design
-
Drugs with FDA adverse-event history: 3 (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
- 2
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 19 (typical: 18)
- Maximum age
- 65 (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 312 (typical: 32)
- Sponsor's past termination rate
- 3.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 152 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 103347 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 21792 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 23.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- cyclophosphamide, doxorubicin, pegfilgrastim
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
- Intermittent G-CSF in Patients With Breast Cancer Receiving Adjuvant Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) NCT02685111 · started 2016 · scored riskier than 70% of active trials terminated
- Reduced Dose of Pegfilgrastim as Support for Chemotherapy for Breast Cancer NCT05283616 · started 2017 · scored riskier than 30% of active trials completed
- Nanogen Pegfilgrastim (Pegcyte) PK/PD Clinical Study in Breast Cancer Patients NCT03376503 · started 2016 · scored riskier than 25% of active trials completed
- SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE) NCT02643420 · started 2016 · scored riskier than 60% of active trials completed
- SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide NCT02953340 · started 2017 · scored riskier than 56% 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.