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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
difficulties for including diabetic patients
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
difficulty in achieving target enrollment numbers
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
difficulty in patients's inclusion
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
difficulty in recruiting patients
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
difficulty in recruiting subjects
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
difficulty in recruitment
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
difficulty obtaining required data
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
difficulty of enrolling patients
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
difficulty of recrutement
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
difficulty to include patients
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
difficulty with accrual
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
drug not available
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
drug withdrawn from market
[ "Study_Design" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
drug-related harm
[ "Safety_Sideeffects" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
true
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 (at least until 25 APRIL 2020)
[ "Covid19" ]
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
due to COVID-19 restrictions
[ "Covid19" ]
false
false
true
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 lack of finance
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
due to low enrollment
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
due to low study enrollment
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
due to multiple subjects reporting pain and burning at the phlebotomy sites after 38hr
[ "Safety_Sideeffects" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
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 recruitment problems / based on recommendation of Independent Review Board
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
due to slow recruitment
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
due to slow recruitment of patients
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
due to strong side effect
[ "Safety_Sideeffects" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
due to very low recruitment. For this reason, there will be no further analysis and reporting of this study."
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
during Period 1 due to numerous orthostatic AEs that occurred. Subsequently, RLD was reduced to 5 mg due to safety concerns."
[ "Safety_Sideeffects" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
early termination due to loss of interest and low enrollment of patient
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
early termination due to slow recruitment
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
echo contrast agents no longer allowed in CAD patients.
[ "Study_Design" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
end of the follow-up period
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
enough patients have been enrolled for the statistic analysis
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
enrolling participants stopped
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
enrollment completed
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
enrollment criteria not met by PI patient population
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
enrollment difficult due to inclusion/exclusion criteria/protocol requirements
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
enrollment insufficient: lack of motivated patients
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
enrollment stopped for safety issues
[ "Safety_Sideeffects" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
enrollment was completed
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
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
extremely slow enrollment
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
failed recruitment efforts
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
failure of recruiting a sufficient number of patients
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
failure to accrue
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
feasibility and low enrollment
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
feasibility issues
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
financial reasons
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
financial support withdrawn
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
following DSMB recommandation.
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
for administrative reasons
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
for lack of recruitment
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
four adverse events encountered
[ "Safety_Sideeffects" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
funding
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
funding exhausted
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
funding was withdrawn
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
funding was withdrawn from Drug company
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
funding withdrawn
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
futility
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
ganaxolone did not significantly reduce spasms after an 8-day placebo control period
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
grant funding ended and lack of sufficient participants to complete trial
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
grant was not approved.
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
higher incidence of pain related sexual dysfunction in the TO arm
[ "Safety_Sideeffects" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
images obtained were non-diagnostic
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
immunohistochemistry markers are not recieved yet
[ "Logistics_Resources" ]
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
inability to recruit due to administrative difficulties at the site
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
inactive
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
inadequate enrollment
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
inadequate number of enrolled study subjects
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
inadequate recruitment
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
inclusion was finished
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
inconclusive results, market feasiblity"
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
insufficent enrolement
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
insufficient enrollment
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
insufficient enrollment rate
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
insufficient enrolment
[ "Another_Study" ]
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
insufficient funding
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
insufficient number of eligible subjects
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
insufficient numbers of eligible patients as laparscopic surgery increased and open surgery decreased.
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
insufficient recruitment
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
insufficient recruitment/enrollment
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
interim analysis
[ "Interim_Analysis" ]
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
interim analysis found no difference in LB rate and lower than expected event rate
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
interim analysis indicates statistical futility for primary outcomes
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
interim analysis showed significant differences between two treatment groups
[ "Endpoint_Met" ]
false
false
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
interim analysis suggested no differences with whole sample
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
interim review of the data indicated that the hypothesis put forth on the efficacy of a 3 day regimen was not met.
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
intermediate analysis
[ "Negative" ]
false
false
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
investigation of adverse events
[ "Safety_Sideeffects" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
false
false
investigation of adverse events in a related clinical study
[ "Another_Study" ]
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
investigator closed study
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
is finish
[ "Invalid_Reason" ]
false
false
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
it was not possible to recruit any patient in the study
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
it was not possible to recruit new patients anymore
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
key investigator relocated.
[ "Study_Staff_Moved" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
key personnel left institution
[ "Study_Staff_Moved" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
key study staff left foundation
[ "Study_Staff_Moved" ]
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false
true
false
lack of accrual
[ "Insufficient_Enrollment" ]
false
false
false
false
false
false
true
false
false
false
false
false
false
false
false
false
false
lack of appropriate funding
[ "Business_Administrative" ]
false
true
false
false
false
false
false
false
false
false
false
false
false
false
false
false
false