An Extension Study of TAK-664 for Japanese People With Primary Immunodeficiency Disease
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 9% of the time (336 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-04-25, after 2021-04-27 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 2024-04-25. 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
-
Sponsor's past termination rate: 11.9% (raises risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 44 (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: No (lowers risk) · Design
-
Sponsor's past trials: 504 (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: industry (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
-
Drug's FAERS reports with a death: 20.5% (lowers risk) · Drug's FDA history
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: completedlong termextensiontreatedtolerability
Phrases that lowered it: participantaim of20open labelproduct
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
- 3 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 2 (typical: 18)
- Maximum age
- not given (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
- 504 (typical: 32)
- Sponsor's past termination rate
- 11.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 44 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 1947 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 20.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- immunology
- Drugs matched to FDA substances
- immune globulin human
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
- A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants NCT05513586 · started 2022 · scored riskier than 28% of active trials completed
- A Study of TAK-771 in Japanese People With Primary Immunodeficiency Diseases (PID) NCT05150340 · started 2022 · scored riskier than 38% of active trials completed
- Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study) NCT01461018 · started 2011 · scored riskier than 19% of active trials completed
- A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases NCT05755035 · started 2023 · scored riskier than 20% of active trials completed
- Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (EU Extension Study) NCT00751621 · started 2008 · scored riskier than 24% 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.