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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
Drug company decided to terminate all sponsored clinical studies involving rilotumumab.
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Drug company withdrawal of support for investigational agent in this indication.
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Drug development suspended
[ "Business_Administrative", "Logistics_Resources" ]
false
true
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
Drug exposure of retaspimycin HCl was superior to IPI-493, Infinity will focus on RetaspimycinÊ HCL
[ "Success", "Endpoint_Met" ]
false
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
true
Drug related AEs observed upon repeat dosing that with longer treatment duration could becomeÊ worse. Required action on some biomarkers not observed.
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
Drug sold to Sanofi-Aventis who sold it to GSK; OBS no longer owns study and does not have data.
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Drug supply issue - Contracts with New source Genzyme Canada are in negotiation
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
Drug supply shortage. Study should reopen in February, 2008"
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
Drug supply unavailable.
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
Drug unavailable
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
Drug was not sent
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
Drug was pulled from the market.
[ "Study_Design" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
Drug withdrawal
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
Drug withdrawn from market
[ "Business_Administrative", "Study_Design" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
Drugs unavailable- study terminated 1/2/18
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
Drugs unavailable:unable to make radioactive topotecan
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
Due to COVID -19
[ "Covid19" ]
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Due to COVID -19, study is suspended to accrual only
[ "Covid19" ]
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Due to COVID-19
[ "Covid19" ]
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Due to COVID-19 and tissue resource not available at this time
[ "Covid19", "Logistics_Resources" ]
false
false
true
false
false
false
false
false
false
true
false
false
false
false
false
false
false
Due to COVID-19 outbreak, study is temporarily suspended.
[ "Covid19" ]
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Due to COVID-19 policies.
[ "Covid19" ]
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Due to COVID-19, effective 3/19/2020 recruitment is halted until further notice
[ "Covid19" ]
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Due to COVID-19.
[ "Covid19" ]
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Due to FDA comments, indications for use were chnaged and a different population will be proposed shortly"
[ "Study_Design" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
Due to Health Canada losartan recall, a new formulation being added to the protocol/ temporaryÊ suspension
[ "Study_Design", "Safety_Sideeffects" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
true
true
false
false
Due to MOH request.
[ "Regulatory" ]
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
Due to PI's Study_Design with IRB requirements
[ "Study_Design" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
Due to Protocol AC-055B201 (MUSIC) not meeting it's primary end point
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
Due to Sponsor's decision, only 12 patients were randomized & completed study.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to Sponsor's financial reasons
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Due to a lack of IP supply and then terminated because they were combined into one new study with the new IP formulation.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to a low recruitment rate since start of recruitment period.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to a single, unexpected serious event, the trial was stopped.
[ "Safety_Sideeffects" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
Due to a substantial response to placebo an interim analysis indicated the need for a larger than expected study population to achieve the level of significance
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
Due to administrative reasons
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Due to administrative reasons not related to efficacy or safety.
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Due to an administrative reason
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Due to business considerations; not due to toxicities or adverse events.
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Due to business decisions
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Due to celecoxib safety issues
[ "Safety_Sideeffects" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
Due to changes in portofolio review
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Due to clinical trial supplies shortage
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
Due to company decision to focus resources on a larger, controlled study in this patient population."
[ "Another_Study" ]
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Due to company decision to focus resources on the finalisation of three ongoing studies in the region
[ "Another_Study" ]
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Due to concerns about potential liver safety (See Detailed Description)
[ "Safety_Sideeffects" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
Due to continuing review
[ "Regulatory" ]
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
Due to country-level restrictions regarding COVID19
[ "Covid19" ]
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Due to decrease in Avaulta mesh kit usage & inability to recruit study subjects.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to difficult enrollment, and investigator agreed to terminate this study."
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to difficult patient enrollment.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to difficulty in patient recruitment
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to difficulty with enrollment of subjects
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to dose re-selection
[ "Study_Design" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
Due to drug unavailability
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
Due to efficacy results of interim analysis
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
Due to emerging safety data
[ "Safety_Sideeffects" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
Due to enrollment challenges resulting from changing treatment patterns in the use ofÊ cetuximab, the study has been terminated. No patients remain on study.
[ "Study_Design", "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
true
false
false
Due to ethical concerns regard to the results from the WHI study
[ "Another_Study" ]
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Due to existing evidence eligible patients receive CRT treatment in first place
[ "Another_Study" ]
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Due to extreme toxicity
[ "Safety_Sideeffects" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
Due to failure to control sufficient patients in the active arm, this study has now been closed."
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to financial issues of Restora spacer company.
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
Due to funding issues.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to graft failure.
[ "Study_Design" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
Due to high incidence of neurological complication in those with ilioinguinal block
[ "Safety_Sideeffects" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
Due to inadequate recruitment
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to insufficient funds
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Due to insufficient patient inclusion the study has been stopped prematurely.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to internal reasons study was not performed.
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
Due to lack of availability of study participants to accommodate the study design
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to lack of coordinator coverage
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
Due to lack of efficacy
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
Due to lack of funding
[ "Business_Administrative", "Logistics_Resources" ]
false
true
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
Due to lack of funding and a primary co-investigator of the trial leaving the institution.
[ "Business_Administrative", "Logistics_Resources", "Study_Staff_Moved" ]
false
true
false
false
false
false
false
false
false
true
false
false
false
false
false
true
false
Due to lack of malaria patients in Zanzibar the study has been suspended.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to lack of recruitment
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to lack of recruitment and loss of the French principal investigator.
[ "Insufficient_Enrollment", "Study_Staff_Moved" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
true
false
Due to lack of sufficient efficacy.
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
Due to lack of supply of the investigational product.
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
Due to late study start, the possibility to enroll enough subjects dropped below the limit toÊ provide scientifically acceptable data, hence study was cancelled.
[ "Insufficient_Enrollment", "Insufficient_Data", "Study_Design" ]
false
false
false
false
false
true
true
false
false
false
false
false
false
false
true
false
false
Due to limited pool of eligble WNV patients
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to low accrual
[ "Logistics_Resources", "Business_Administrative", "Insufficient_Enrollment" ]
false
true
false
false
false
false
true
false
false
true
false
false
false
false
false
false
false
Due to no patient enrollment this study was withdrawn/closed
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to non-feasibility
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
Due to numerous delays in study start-up process...
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
Due to other projects priority
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Due to poor accrual
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to poor accrual of the study
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to poor compliance with study drug administration.
[ "Study_Design" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
Due to poor enrollment
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to poor enrollment rate
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to poor enrollment, this study was terminated."
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to poor patient enrollment
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to poor patient recruitment, a decision was made to terminate this trial."
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to portfolio and logistical issues, this study will not be re-started at the present time. The study is not being terminated for safety reasons."
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Due to portfolio/business decisions by the sponsor
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Due to potential concerns about liver safety (See Detailed Description)
[ "Safety_Sideeffects" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
Due to projected low enrollment, UroGen has decided not to move forward with the study.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Due to recent findings relating MRI contrast to nephrogenic systemic fibrosis
[ "Another_Study" ]
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false