text
stringlengths 4
164
| label_descriptions
list | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Decision to obtain PK data at a later date
|
[
"No_Context"
] | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false |
Decision to stop study due to low recruitment.
|
[
"Insufficient_Enrollment",
"Study_Design"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | true | false | false |
Decision to terminate recruitment on this study was based on lack of efficacy observed to date
|
[
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Decision was taken by Wyeth Sr. Management to early terminate the 3100N7-210 study (terminate enrollment but complete follow-up).
|
[
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Definitive discontinuation according to safety monitoring of death from the 46th patientÊ onwards.
|
[
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
Delay in the R&D stage
|
[
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
Delayed recruitment
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Delayed recruitment as compared to that expected
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Delayed start of the trial, both treatment options already have market authorizations, study Ê medication expired
|
[
"Invalid_Reason"
] | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false |
Delayed to review safety data
|
[
"Interim_Analysis"
] | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false |
Departure of the investigator coordinator into other country
|
[
"Logistics_Resources",
"Study_Staff_Moved"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | true | false |
Despite considerable efforts to boost recruitment during the final year of the study, no newÊ patients were enrolled.
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Development of Current Formulation has Ceased
|
[
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
Development of JNJ-64041757 in combination with nivolumab discontinued due to lack of clinicalÊ benefit observed in the Phase 1b portion of the study
|
[
"Study_Design",
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | true | false | false |
Development of XL999 was stopped due to cardiac toxicities in the subjects
|
[
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
Development of tasquinimod in prostate cancer discontinued
|
[
"Study_Design"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false |
Development of this compound was discontinued.
|
[
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Development program ended due to inability to pair with other cytidine analogs and higher riskÊ of hyperlipasemia when not used with 3TC/FTC.
|
[
"Safety_Sideeffects",
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | true | false | false | false |
Development program terminated.
|
[
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Development project stopped
|
[
"No_Context"
] | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false |
Device superceded by next generation device. Enrollment stopped, long term follow up was completed in August of 2004."
|
[
"Study_Design"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false |
Did not get approval
|
[
"Ethical_Reason",
"Business_Administrative"
] | false | true | false | false | true | false | false | false | false | false | false | false | false | false | false | false | false |
Did not meet accrual goals.
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Did not meet enrollment goals
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Did not meet predetermined primary endpoint
|
[
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Did not meet the criteria for continuation to second stage
|
[
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Did not reach enrollment goals
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Did not receive budget needed.
|
[
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Did not recruit
|
[
"Invalid_Reason"
] | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false |
Did not support the planned development of DCCR in the new indication
|
[
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Did not want to enroll and proceed with this study concept.
|
[
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Didn't receive IND exemption. PI withdrew rather than reapply to FDA. No patients enrolled.
|
[
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Difficualty in recruiting patients
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficult enrollment
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficult getting subjects
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficult of recruiting
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficult recruitment -
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficult to recruit participants
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulties in finding enough study participants.
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulties in getting suitable applicators for biodegradable stents.
|
[
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
Difficulties in logistics handling the very severe patients (travel, hospital stay, follow-up)
|
[
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
Difficulties in manufacturing the cell products essential to the study.
|
[
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
Difficulties in recruiting enough subjects
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulties in recruiting patients
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulties in recruitment - will require longer time to achieve sample size
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulties in the organisation
|
[
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Difficulties of recruitment, lack of elligible patients"
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulties with recruitment
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficultly in enrolling
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulty enrolling eligible subjects
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulty enrolling patients
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulty enrollment, no patients received treatment
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulty finding eligible participants and lack of funding.
|
[
"Logistics_Resources",
"Business_Administrative",
"Insufficient_Enrollment"
] | false | true | false | false | false | false | true | false | false | true | false | false | false | false | false | false | false |
Difficulty finding eligible sites/patients:current situation in health policy cause negative effects on existing/planned contracts for integrated care programs
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulty finding eligible sites/patients; current situation in health policy cause negative effect on existing/planned contracts for integrated care program
|
[
"Logistics_Resources",
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | true | false | false | false | false | false | false | false |
Difficulty finding the required patient population
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulty finding the required subject population
|
[
"Insufficient_Enrollment",
"Insufficient_Data"
] | false | false | false | false | false | true | true | false | false | false | false | false | false | false | false | false | false |
Difficulty in accrual of study subjects, small numbers of potential subjects"
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulty in identifying subjects satisfying the inclusion criteria.
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulty in recruiting
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulty in recruiting and maintenance of blinding necessary for the trial
|
[
"Insufficient_Enrollment",
"Study_Design"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | true | false | false |
Difficulty in recruiting patients for the study
|
[
"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 in recruting patients
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulty meeting patient accrual goals
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulty obtaining enrollment
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulty of participant enrollment.
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulty of realization of the study
|
[
"No_Context"
] | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false |
Difficulty recruiting
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulty recruiting (early discharge scheme initiated)
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulty recruiting eligible patients in timely fashion
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulty recruiting subjects
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulty recruiting subjects to dosing cohort 5.
|
[
"Insufficient_Enrollment",
"Study_Design"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | true | false | false |
Difficulty to include patient
|
[
"Logistics_Resources",
"Insufficient_Enrollment",
"Study_Design"
] | false | false | false | false | false | false | true | false | false | true | false | false | false | false | true | 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 to keep children in randomly assigned groups.
|
[
"Study_Design"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false |
Difficulty with accrual
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Difficulty with enrollment
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Dificulties in the recruitment of patients.
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Discontinuation of program
|
[
"Business_Administrative",
"No_Context"
] | false | true | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false |
Discontinuation of the development
|
[
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
Discontinued PB127 development program for business reasons
|
[
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Discontinued cystitis study due to poor recruitment. To continue the trial under theseÊ circumstances is considered non-viable.
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Discontinued due to company's strategic reason
|
[
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Discontinued due to incomplete recruitment
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Discontinued due to non-enrollment.
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Dissatisfactory enrollment rate
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Dose levels were determined to be subtherapeutic
|
[
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Dose limiting tox is observed. Study put on full clinical hold.
|
[
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
Dose limiting toxicities on lowest dose level
|
[
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
Dosing stopped
|
[
"No_Context"
] | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false |
Dr. Grose has left this practice, this study is terminated"
|
[
"Study_Staff_Moved"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false |
Dr. Holguin is relocating.
|
[
"Study_Staff_Moved"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false |
Dr. Jorizzo has decided to withdraw from this study due to the time it is taking to get the study started.
|
[
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Dr. Milla has left University of Minnesota. The study is no longer being conducted at this site.
|
[
"Study_Staff_Moved"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false |
Dr. Vindas completed his fellowship + low enrollment
|
[
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Drug (Aflibercept) no longuer available for the study
|
[
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
Drug Manufacturer withdrew support for studies not in metastatic breast cancer
|
[
"Business_Administrative",
"Logistics_Resources"
] | false | true | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
Drug combination is no longer pursued
|
[
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
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