opentargets/clinical_trial_reason_to_stop · Datasets at Hugging Face

text stringlengths 4 164	label_descriptions sequence	Another_Study bool 2 classes	Business_Administrative bool 2 classes	Covid19 bool 2 classes	Endpoint_Met bool 2 classes	Ethical_Reason bool 2 classes	Insufficient_Data bool 2 classes	Insufficient_Enrollment bool 2 classes	Interim_Analysis bool 2 classes	Invalid_Reason bool 2 classes	Logistics_Resources bool 2 classes	Negative bool 2 classes	No_Context bool 2 classes	Regulatory bool 2 classes	Safety_Sideeffects bool 2 classes	Study_Design bool 2 classes	Study_Staff_Moved bool 2 classes	Success bool 2 classes
Enrollment goals not met	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Enrollment goals unable to be reached.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Enrollment has been terminated due to a slow rate of enrollment.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Enrollment into acute phase therapy ended August 1st, 2008. Randomized continuation phase trial is slated to end in June 2009 and follow-up to end in June 2011."	[ "Invalid_Reason" ]	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false
Enrollment into study was slower than expected.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Enrollment is paused due to COVID-19. This is not a suspension of IRB approval.	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Enrollment is pending further analysis of the stability of exendin-(9-39) at higherÊ concentrations.	[ "Interim_Analysis" ]	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false
Enrollment is suspended due to COVID-19.	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Enrollment is temporarily paused due to COVID-19 and is expected to reopen in the future. This	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Enrollment is temporarily paused due to COVID-19 and is expected to reopen in the future. ThisÊ is not a suspension of IRB approval.	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Enrollment is temporarily paused due to COVID-19; interactions/interventions with current	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Enrollment not initiated for study.	[ "Insufficient_Enrollment", "Invalid_Reason" ]	false	false	false	false	false	false	true	false	true	false	false	false	false	false	false	false	false
Enrollment of patients has halted prematurely and will not resume. No future patients will be enrolled or treated.	[ "Invalid_Reason" ]	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false
Enrollment on Hold (COVID-19)	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Enrollment on hold due to COVID-19 pandemic.	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Enrollment rate was too slow.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Enrollment slower than expected	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Enrollment stopped prior to Phase 1b, change in strategic focus	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Enrollment stopped until further notice due to COVID-19 restrictions	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Enrollment suspended based upon interim analysis; subjects allowed to stay on study until disease progression.	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Enrollment suspended due to COVID-19 pandemic	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Enrollment suspended due to COVID-19, pre-screening continues for future enrollment	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Enrollment suspended due to COVID-19, prescreening continues for future enrollment	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Enrollment suspended due to low drug exposure.	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Enrollment suspended due to protocol amendment	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Enrollment suspended during the COVID-19 pandemic	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Enrollment target not reached	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Enrollment temporarily suspended to prepare grant; need IRB reapproval	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Enrollment temporarily suspended, while protocol is being revised"	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Enrollment too difficult	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Enrollment was completed with insufficient sample size for publishable results	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Enrollment was difficult	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Enrollment was much slower than anticipated, leading to a decision to terminate the studyÊ early for enrollment futility.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Enrollment was slow and we decided to refocus our efforts on other studies	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Enrollment was slower than anticipated.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Enrollment was stopped based on the Data Monitoring Committee's recommendation.	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Enrollment was too low.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Enrollment was too slow	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Enrollment was too slow and principal investigator moved to another country	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Enrollment.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Ethics Committee approval denied	[ "Ethical_Reason" ]	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false
Ethics approval denied	[ "Ethical_Reason" ]	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false
Evaluation of surgical technique	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Evident advantages of one treatment (seton) over the other (Tissucol Glue)	[ "Endpoint_Met" ]	false	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false
Evolution of patient's care allows no more recruitment	[ "Insufficient_Enrollment", "Study_Design" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	true	false	false
Evotec has indicated that this study was discontinued due to a clinical hold issued by the FDA	[ "Regulatory" ]	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false
Excess toxicity	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
Executive committee determined to close study after interim analysis.	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Exhausted personel after a long recruiting period	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Existing vessel analysis software could not be applied to breast MRI data.	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Expected mortality rates in placebo and treatment groups lower than predicted	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Experience gained from this study is sufficient to design and facilitate the follow-on study	[ "Invalid_Reason" ]	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false
Experience gained from this study is sufficient to design and facilitate the follow-on study.	[ "Success" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true
Experimental arm (induction + low dose tacrolimus) not effective.	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Experimental results were unsatisfatory compared with control.	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Expiration of current lot of MEDI-507, ongoing discussion about future source of MEDI-507"	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Expired IRB approval	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Expired for lack of continuing review	[ "Regulatory" ]	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false
Exploratory study proactively terminated by Roche after slow enrollment due to concerns regarding the CV safety profile of TZDs in patients with symptomatic CHF	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Extreme toxicity in Phase I, study did not proceed to Phase II	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
F Funding Expiration	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
FDA Clinical Hold	[ "Regulatory" ]	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false
FDA Clinical Hold as of 12/21/07 due to safety concerns	[ "Safety_Sideeffects", "Regulatory" ]	false	false	false	false	false	false	false	false	false	false	false	false	true	true	false	false	false
FDA Hold May 2007	[ "Business_Administrative", "Regulatory" ]	false	true	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false
FDA agreed to early termination of the study due to difficulties enrolling patients.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
FDA concerns regarding Avandamet	[ "Safety_Sideeffects", "Regulatory" ]	false	false	false	false	false	false	false	false	false	false	false	false	true	true	false	false	false
FDA drug recall on July 30, 2010	[ "Study_Design", "Regulatory" ]	false	false	false	false	false	false	false	false	false	false	false	false	true	false	true	false	false
FDA has placed all trials involving Pacritinib on Full Clinical Hold	[ "Regulatory" ]	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false
Facet no longer has ownership of ularitide.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Fail of applying funding	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Failed primary endpoint	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Failed to enroll patients	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Failure of an inroducer sheath used in the technique specified by the study. posing a risk. No adverse outcome has occurred in a study patient.	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
Failure rate was 100% in one arm of the study (the intervention)	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Failure to Recruit in a Timely manner	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Failure to demonstrate a tolerable dose that had potential for efficacy.	[ "Study_Design", "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	true	false	false
Failure to include	[ "No_Context" ]	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false
Failure to recruit	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Failure to recruit due to polypharmacy	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Failure to recruit enough patients	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Failure to recruit patients with membranous lupus nephritis not previously treated with azathioprine .	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Failure to recruit sufficient participants	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Failure to recruit sufficient participants.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Failure to secure adequate funding	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Feasibility and low enrollment	[ "Study_Design", "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	true	false	false
Feasibility concerns due to changes in standard of care	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Feasibility issues, only 1 patient recruited."	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Felt not to show benefit over control per DMC and confirmed via futility analysis	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Few subjects recruited, sponsor withdrew support."	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Field Safety Notice related to potential ventricular oversensing associated to the PhD featureÊ on Paradym ICDs	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
Final study report has been completed and submitted	[ "Invalid_Reason" ]	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false
Financial Constraints	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Financial and administrative matters did not allow collaboration among centers.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Financial concerns with device manufacturer.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Financial constraints	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Financial difficulties	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Financing and re-organization	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
First subject over five years after the transplant. The second subject is not in compliance Ê with follow ups. We do not plan to enroll more subjects.	[ "Study_Design", "Insufficient_Data" ]	false	false	false	false	false	true	false	false	false	false	false	false	false	false	true	false	false
First two patients enrolled after trial reopened, developed grade III-IV acute GVHD and Ê subsequently passed away.	[ "Safety_Sideeffects", "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	true	false	false	false
FlowMedica was purchased by AngioDynamics. Study will be re-started by AngioDynamics.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false

Enrollment goals not met

[ "Insufficient_Enrollment" ]

false

true

false

Enrollment goals unable to be reached.

[ "Insufficient_Enrollment" ]

false

true

false

Enrollment has been terminated due to a slow rate of enrollment.

[ "Insufficient_Enrollment" ]

false

true

false

Enrollment into acute phase therapy ended August 1st, 2008. Randomized continuation phase trial is slated to end in June 2009 and follow-up to end in June 2011."

[ "Invalid_Reason" ]

false

true

false

Enrollment into study was slower than expected.

[ "Insufficient_Enrollment" ]

false

true

false

Enrollment is paused due to COVID-19. This is not a suspension of IRB approval.

[ "Covid19" ]

false

true

false

Enrollment is pending further analysis of the stability of exendin-(9-39) at higherÊ concentrations.

[ "Interim_Analysis" ]

false

true

false

Enrollment is suspended due to COVID-19.

[ "Covid19" ]

false

true

false

Enrollment is temporarily paused due to COVID-19 and is expected to reopen in the future. This

[ "Covid19" ]

false

true

false

Enrollment is temporarily paused due to COVID-19 and is expected to reopen in the future. ThisÊ is not a suspension of IRB approval.

[ "Covid19" ]

false

true

false

Enrollment is temporarily paused due to COVID-19; interactions/interventions with current

[ "Covid19" ]

false

true

false

Enrollment not initiated for study.

[ "Insufficient_Enrollment", "Invalid_Reason" ]

false

true

false

true

false

Enrollment of patients has halted prematurely and will not resume. No future patients will be enrolled or treated.

[ "Invalid_Reason" ]

false

true

false

Enrollment on Hold (COVID-19)

[ "Covid19" ]

false

true

false

Enrollment on hold due to COVID-19 pandemic.

[ "Covid19" ]

false

true

false

Enrollment rate was too slow.

[ "Insufficient_Enrollment" ]

false

true

false

Enrollment slower than expected

[ "Insufficient_Enrollment" ]

false

true

false

Enrollment stopped prior to Phase 1b, change in strategic focus

[ "Business_Administrative" ]

false

true

false

Enrollment stopped until further notice due to COVID-19 restrictions

[ "Covid19" ]

false

true

false

Enrollment suspended based upon interim analysis; subjects allowed to stay on study until disease progression.

[ "Negative" ]

false

true

false

Enrollment suspended due to COVID-19 pandemic

[ "Covid19" ]

false

true

false

Enrollment suspended due to COVID-19, pre-screening continues for future enrollment

[ "Covid19" ]

false

true

false

Enrollment suspended due to COVID-19, prescreening continues for future enrollment

[ "Covid19" ]

false

true

false

Enrollment suspended due to low drug exposure.

[ "Study_Design" ]

false

true

false

Enrollment suspended due to protocol amendment

[ "Study_Design" ]

false

true

false

Enrollment suspended during the COVID-19 pandemic

[ "Covid19" ]

false

true

false

Enrollment target not reached

[ "Insufficient_Enrollment" ]

false

true

false

Enrollment temporarily suspended to prepare grant; need IRB reapproval

[ "Business_Administrative" ]

false

true

false

Enrollment temporarily suspended, while protocol is being revised"

[ "Study_Design" ]

false

true

false

Enrollment too difficult

[ "Insufficient_Enrollment" ]

false

true

false

Enrollment was completed with insufficient sample size for publishable results

[ "Study_Design" ]

false

true

false

Enrollment was difficult

[ "Insufficient_Enrollment" ]

false

true

false

Enrollment was much slower than anticipated, leading to a decision to terminate the studyÊ early for enrollment futility.

[ "Insufficient_Enrollment" ]

false

true

false

Enrollment was slow and we decided to refocus our efforts on other studies

[ "Insufficient_Enrollment" ]

false

true

false

Enrollment was slower than anticipated.

[ "Insufficient_Enrollment" ]

false

true

false

Enrollment was stopped based on the Data Monitoring Committee's recommendation.

[ "Negative" ]

false

true

false

Enrollment was too low.

[ "Insufficient_Enrollment" ]

false

true

false

Enrollment was too slow

[ "Insufficient_Enrollment" ]

false

true

false

Enrollment was too slow and principal investigator moved to another country

[ "Insufficient_Enrollment" ]

false

true

false

Enrollment.

[ "Insufficient_Enrollment" ]

false

true

false

Ethics Committee approval denied

[ "Ethical_Reason" ]

false

true

false

Ethics approval denied

[ "Ethical_Reason" ]

false

true

false

Evaluation of surgical technique

[ "Study_Design" ]

false

true

false

Evident advantages of one treatment (seton) over the other (Tissucol Glue)

[ "Endpoint_Met" ]

false

true

false

Evolution of patient's care allows no more recruitment

[ "Insufficient_Enrollment", "Study_Design" ]

false

true

false

true

false

Evotec has indicated that this study was discontinued due to a clinical hold issued by the FDA

[ "Regulatory" ]

false

true

false

Excess toxicity

[ "Safety_Sideeffects" ]

false

true

false

Executive committee determined to close study after interim analysis.

[ "Negative" ]

false

true

false

Exhausted personel after a long recruiting period

[ "Logistics_Resources" ]

false

true

false

Existing vessel analysis software could not be applied to breast MRI data.

[ "Logistics_Resources" ]

false

true

false

Expected mortality rates in placebo and treatment groups lower than predicted

[ "Study_Design" ]

false

true

false

Experience gained from this study is sufficient to design and facilitate the follow-on study

[ "Invalid_Reason" ]

false

true

false

Experience gained from this study is sufficient to design and facilitate the follow-on study.

[ "Success" ]

false

true

Experimental arm (induction + low dose tacrolimus) not effective.

[ "Negative" ]

false

true

false

Experimental results were unsatisfatory compared with control.

[ "Negative" ]

false

true

false

Expiration of current lot of MEDI-507, ongoing discussion about future source of MEDI-507"

[ "Logistics_Resources" ]

false

true

false

Expired IRB approval

[ "Business_Administrative" ]

false

true

false

Expired for lack of continuing review

[ "Regulatory" ]

false

true

false

Exploratory study proactively terminated by Roche after slow enrollment due to concerns regarding the CV safety profile of TZDs in patients with symptomatic CHF

[ "Insufficient_Enrollment" ]

false

true

false

Extreme toxicity in Phase I, study did not proceed to Phase II

[ "Safety_Sideeffects" ]

false

true

false

F Funding Expiration

[ "Business_Administrative" ]

false

true

false

FDA Clinical Hold

[ "Regulatory" ]

false

true

false

FDA Clinical Hold as of 12/21/07 due to safety concerns

[ "Safety_Sideeffects", "Regulatory" ]

false

true

false

FDA Hold May 2007

[ "Business_Administrative", "Regulatory" ]

false

true

false

true

false

FDA agreed to early termination of the study due to difficulties enrolling patients.

[ "Insufficient_Enrollment" ]

false

true

false

FDA concerns regarding Avandamet

[ "Safety_Sideeffects", "Regulatory" ]

false

true

false

FDA drug recall on July 30, 2010

[ "Study_Design", "Regulatory" ]

false

true

false

true

false

FDA has placed all trials involving Pacritinib on Full Clinical Hold

[ "Regulatory" ]

false

true

false

Facet no longer has ownership of ularitide.

[ "Business_Administrative" ]

false

true

false

Fail of applying funding

[ "Business_Administrative" ]

false

true

false

Failed primary endpoint

[ "Negative" ]

false

true

false

Failed to enroll patients

[ "Insufficient_Enrollment" ]

false

true

false

Failure of an inroducer sheath used in the technique specified by the study. posing a risk. No adverse outcome has occurred in a study patient.

[ "Safety_Sideeffects" ]

false

true

false

Failure rate was 100% in one arm of the study (the intervention)

[ "Negative" ]

false

true

false

Failure to Recruit in a Timely manner

[ "Insufficient_Enrollment" ]

false

true

false

Failure to demonstrate a tolerable dose that had potential for efficacy.

[ "Study_Design", "Negative" ]

false

true

false

true

false

Failure to include

[ "No_Context" ]

false

true

false

Failure to recruit

[ "Insufficient_Enrollment" ]

false

true

false

Failure to recruit due to polypharmacy

[ "Insufficient_Enrollment" ]

false

true

false

Failure to recruit enough patients

[ "Insufficient_Enrollment" ]

false

true

false

Failure to recruit patients with membranous lupus nephritis not previously treated with azathioprine .

[ "Insufficient_Enrollment" ]

false

true

false

Failure to recruit sufficient participants

[ "Insufficient_Enrollment" ]

false

true

false

Failure to recruit sufficient participants.

[ "Insufficient_Enrollment" ]

false

true

false

Failure to secure adequate funding

[ "Business_Administrative" ]

false

true

false

Feasibility and low enrollment

[ "Study_Design", "Insufficient_Enrollment" ]

false

true

false

true

false

Feasibility concerns due to changes in standard of care

[ "Study_Design" ]

false

true

false

Feasibility issues, only 1 patient recruited."

[ "Logistics_Resources" ]

false

true

false

Felt not to show benefit over control per DMC and confirmed via futility analysis

[ "Negative" ]

false

true

false

Few subjects recruited, sponsor withdrew support."

[ "Insufficient_Enrollment" ]

false

true

false

Field Safety Notice related to potential ventricular oversensing associated to the PhD featureÊ on Paradym ICDs

[ "Safety_Sideeffects" ]

false

true

false

Final study report has been completed and submitted

[ "Invalid_Reason" ]

false

true

false

Financial Constraints

[ "Business_Administrative" ]

false

true

false

Financial and administrative matters did not allow collaboration among centers.

[ "Business_Administrative" ]

false

true

false

Financial concerns with device manufacturer.

[ "Business_Administrative" ]

false

true

false

Financial constraints

[ "Business_Administrative" ]

false

true

false

Financial difficulties

[ "Business_Administrative" ]

false

true

false

Financing and re-organization

[ "Business_Administrative" ]

false

true

false

First subject over five years after the transplant. The second subject is not in compliance Ê with follow ups. We do not plan to enroll more subjects.

[ "Study_Design", "Insufficient_Data" ]

false

true

false

true

false

First two patients enrolled after trial reopened, developed grade III-IV acute GVHD and Ê subsequently passed away.

[ "Safety_Sideeffects", "Negative" ]

false

true

false

true

false

FlowMedica was purchased by AngioDynamics. Study will be re-started by AngioDynamics.

[ "Business_Administrative" ]

false

true

false