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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
No funding for this study
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
No funding was received, no subjects were enrolled
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
No fundings
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
No further local interest in pursuing the study.
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
No inclusions.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No longer acruing data for this study.
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
No longer enrolling patients, not enough enrollment"
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No longer recruiting: participants are no longer being recruited or enrolled
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
No longer relevant for investigation
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
No longer sponsor of trial
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
No longer viable
[ "No_Context" ]
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
No medication
[ "No_Context" ]
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
No more funding
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
No objective responses observed following completion of Phase 1 dose-escalation
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
No participant enrolled
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No participant recruited
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No participants enrolled
[ "Insufficient_Enrollment", "Study_Design", "Invalid_Reason" ]
false
false
false
false
false
false
true
false
true
false
false
false
false
false
true
false
false
No participants enrolled, study terminated."
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No participants enrolled.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No participants recruited, study discontinued."
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No participants satisfied eligibility criteria and were enrolled into the study since July 2008.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No paticipants enrolled
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No patient completed protocol
[ "Insufficient_Data", "Invalid_Reason" ]
false
false
false
false
false
true
false
false
true
false
false
false
false
false
false
false
false
No patient has been included in 9 months because of strict incl/excl criteria
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No patients completed
[ "Study_Design" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
No patients could be recruited and randomized due to other center offering backdoor for treatment.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No patients dosed
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
No patients enrolled after three years
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No patients enrolled and funding has been withdrawn.
[ "Business_Administrative", "Insufficient_Enrollment" ]
false
true
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No patients enrolled during 2 years
[ "Insufficient_Enrollment", "Study_Design" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
true
false
false
No patients enrolled. Study did not start.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No patients enrolled; study terminated.
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
No patients ever enrolled
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
No patients had been accrued.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No patients met eligibility criteria. The study has been closed.
[ "Insufficient_Enrollment", "Study_Design" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
true
false
false
No patients recruited
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No patients recruited into study.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No patients registered; study terminated.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No patients were enrolled because the company that pledged the drug does not yet have itÊ available.
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
No patients were enrolled in the study.
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
No patients were enrolled on the study
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No patients were enrolled.
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
No patients were enrolled. Study terminated for portfolio reasons.
[ "Business_Administrative", "Invalid_Reason" ]
false
true
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
No patients were recruited. Treatment drug expired.
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
No patients were treated due to enrollment challenges.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No recommended Phase II dose was determined.
[ "Study_Design" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
No recruited patients
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No recruitment
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No recruitment on time
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No recruitment was achievable
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No resources available
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
No response seen in patients
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
No responses, study terminated early."
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No safety concerns, the study was terminated due to slow enrollment. All enrolled patients will be followed per protocol."
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No safety signals were noted. The study completed the main phase, additional potential study cohorts not required."
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
No safety signals were noted. The study completed the main phase, additional potential study Ê cohorts not required.
[ "Success" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
true
No safety signals were noted. The study was stopped because it was no longer consistent with the company's scientific and strategic focus.
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
No safety signals were noted. The study was stopped because it was no longer consistent withÊ the company's scientific and strategic focus.
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
No satisfactory acrual
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No study drug available. Same concept with new study drug will be explored in M19TGA study
[ "Logistics_Resources", "Study_Design" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
true
false
false
No study funding available.
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
No study population in Mexico (H1N1). Study withdrawn from IRB consideration.
[ "Insufficient_Enrollment", "Study_Design" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
true
false
false
No study recruitment due to time constraints and lack of support.
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
No subject accrual
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No subject enrolled in nearly 2 years
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No subject meeting criteria
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No subjects enrolled
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No subjects enrolled and PI went to another facility
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No subjects enrolled, bio equivalence study, canceled before active.
[ "Insufficient_Enrollment", "Another_Study" ]
true
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No subjects enrolled. Funding withdrawn by sponsor.
[ "Business_Administrative", "Insufficient_Enrollment", "Study_Design" ]
false
true
false
false
false
false
true
false
false
false
false
false
false
false
true
false
false
No subjects enrolled. Study was canceled before active
[ "Insufficient_Enrollment", "Invalid_Reason" ]
false
false
false
false
false
false
true
false
true
false
false
false
false
false
false
false
false
No subjects recruited
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No subjects were enrolled in this study. Funding ran out.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
No subjects were entered. The study group changed from patients to a healthy volunteers. A healthy-volunteer study is being planned to replace 213.
[ "Another_Study" ]
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
No subjects were ever enrolled. This study was closed at the IRB.
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
No sufficient increase in plasma osmolarity by galactose (one patient included)
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
Non significative preliminary data
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
Non-compliance issues
[ "Regulatory" ]
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
Non-favorable risk/benefit profile with studied dosing regimen
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
Non-protocol feasibility
[ "Regulatory" ]
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
Non-safety related business decision to combine special population protocols
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Non-treatment trials suspended due to COVID-19
[ "Covid19" ]
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Not Stated
[ "No_Context" ]
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
Not able to recruit the estimated number of patients
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Not able to recruit the number required and due to financial difficulty to pay for intralipids
[ "Business_Administrative", "Insufficient_Enrollment" ]
false
true
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Not adequate enrollment (sample size not possible to reach)
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Not approved by CMS
[ "Regulatory" ]
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
Not approved by sponsor
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Not developing product
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Not enough enrollees to obtain a valid conclusion
[ "Insufficient_Enrollment", "Insufficient_Data", "Study_Design" ]
false
false
false
false
false
true
true
false
false
false
false
false
false
false
true
false
false
Not enough enrollement
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Not enough patients/ ethical concerns
[ "Ethical_Reason" ]
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
Not enough recources.
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
Not enough recruitment
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Not enough recruitment during the proposed period.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Not finding patients for including
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
Not funded
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Not funded Administrative formalities not completed
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Not funded at this time.
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
Not going to be conducted
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false