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
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

Decision to obtain PK data at a later date

[ "No_Context" ]

false

true

false

Decision to stop study due to low recruitment.

[ "Insufficient_Enrollment", "Study_Design" ]

false

true

false

true

false

Decision to terminate recruitment on this study was based on lack of efficacy observed to date

[ "Negative" ]

false

true

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

Definitive discontinuation according to safety monitoring of death from the 46th patientÊ onwards.

[ "Safety_Sideeffects" ]

false

true

false

Delay in the R&D stage

[ "Logistics_Resources" ]

false

true

false

Delayed recruitment

[ "Insufficient_Enrollment" ]

false

true

false

Delayed recruitment as compared to that expected

[ "Insufficient_Enrollment" ]

false

true

false

Delayed start of the trial, both treatment options already have market authorizations, study Ê medication expired

[ "Invalid_Reason" ]

false

true

false

Delayed to review safety data

[ "Interim_Analysis" ]

false

true

false

Departure of the investigator coordinator into other country

[ "Logistics_Resources", "Study_Staff_Moved" ]

false

true

false

true

false

Despite considerable efforts to boost recruitment during the final year of the study, no newÊ patients were enrolled.

[ "Insufficient_Enrollment" ]

false

true

false

Development of Current Formulation has Ceased

[ "Logistics_Resources" ]

false

true

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

true

false

true

false

Development of XL999 was stopped due to cardiac toxicities in the subjects

[ "Safety_Sideeffects" ]

false

true

false

Development of tasquinimod in prostate cancer discontinued

[ "Study_Design" ]

false

true

false

Development of this compound was discontinued.

[ "Business_Administrative" ]

false

true

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

true

false

true

false

Development program terminated.

[ "Business_Administrative" ]

false

true

false

Development project stopped

[ "No_Context" ]

false

true

false

Device superceded by next generation device. Enrollment stopped, long term follow up was completed in August of 2004."

[ "Study_Design" ]

false

true

false

Did not get approval

[ "Ethical_Reason", "Business_Administrative" ]

false

true

false

true

false

Did not meet accrual goals.

[ "Insufficient_Enrollment" ]

false

true

false

Did not meet enrollment goals

[ "Insufficient_Enrollment" ]

false

true

false

Did not meet predetermined primary endpoint

[ "Negative" ]

false

true

false

Did not meet the criteria for continuation to second stage

[ "Negative" ]

false

true

false

Did not reach enrollment goals

[ "Insufficient_Enrollment" ]

false

true

false

Did not receive budget needed.

[ "Business_Administrative" ]

false

true

false

Did not recruit

[ "Invalid_Reason" ]

false

true

false

Did not support the planned development of DCCR in the new indication

[ "Business_Administrative" ]

false

true

false

Did not want to enroll and proceed with this study concept.

[ "Business_Administrative" ]

false

true

false

Didn't receive IND exemption. PI withdrew rather than reapply to FDA. No patients enrolled.

[ "Business_Administrative" ]

false

true

false

Difficualty in recruiting patients

[ "Insufficient_Enrollment" ]

false

true

false

Difficult enrollment

[ "Insufficient_Enrollment" ]

false

true

false

Difficult getting subjects

[ "Insufficient_Enrollment" ]

false

true

false

Difficult of recruiting

[ "Insufficient_Enrollment" ]

false

true

false

Difficult recruitment -

[ "Insufficient_Enrollment" ]

false

true

false

Difficult to recruit participants

[ "Insufficient_Enrollment" ]

false

true

false

Difficulties in finding enough study participants.

[ "Insufficient_Enrollment" ]

false

true

false

Difficulties in getting suitable applicators for biodegradable stents.

[ "Logistics_Resources" ]

false

true

false

Difficulties in logistics handling the very severe patients (travel, hospital stay, follow-up)

[ "Logistics_Resources" ]

false

true

false

Difficulties in manufacturing the cell products essential to the study.

[ "Logistics_Resources" ]

false

true

false

Difficulties in recruiting enough subjects

[ "Insufficient_Enrollment" ]

false

true

false

Difficulties in recruiting patients

[ "Insufficient_Enrollment" ]

false

true

false

Difficulties in recruitment - will require longer time to achieve sample size

[ "Insufficient_Enrollment" ]

false

true

false

Difficulties in the organisation

[ "Business_Administrative" ]

false

true

false

Difficulties of recruitment, lack of elligible patients"

[ "Insufficient_Enrollment" ]

false

true

false

Difficulties with recruitment

[ "Insufficient_Enrollment" ]

false

true

false

Difficultly in enrolling

[ "Insufficient_Enrollment" ]

false

true

false

Difficulty enrolling eligible subjects

[ "Insufficient_Enrollment" ]

false

true

false

Difficulty enrolling patients

[ "Insufficient_Enrollment" ]

false

true

false

Difficulty enrollment, no patients received treatment

[ "Insufficient_Enrollment" ]

false

true

false

Difficulty finding eligible participants and lack of funding.

[ "Logistics_Resources", "Business_Administrative", "Insufficient_Enrollment" ]

false

true

false

true

false

true

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

true

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

true

false

true

false

Difficulty finding the required patient population

[ "Insufficient_Enrollment" ]

false

true

false

Difficulty finding the required subject population

[ "Insufficient_Enrollment", "Insufficient_Data" ]

false

true

false

Difficulty in accrual of study subjects, small numbers of potential subjects"

[ "Insufficient_Enrollment" ]

false

true

false

Difficulty in identifying subjects satisfying the inclusion criteria.

[ "Insufficient_Enrollment" ]

false

true

false

Difficulty in recruiting

[ "Insufficient_Enrollment" ]

false

true

false

Difficulty in recruiting and maintenance of blinding necessary for the trial

[ "Insufficient_Enrollment", "Study_Design" ]

false

true

false

true

false

Difficulty in recruiting patients for the study

[ "Insufficient_Enrollment" ]

false

true

false

Difficulty in recruiting subjects

[ "Insufficient_Enrollment" ]

false

true

false

Difficulty in recruitment

[ "Insufficient_Enrollment" ]

false

true

false

Difficulty in recruting patients

[ "Insufficient_Enrollment" ]

false

true

false

Difficulty meeting patient accrual goals

[ "Insufficient_Enrollment" ]

false

true

false

Difficulty obtaining enrollment

[ "Insufficient_Enrollment" ]

false

true

false

Difficulty of participant enrollment.

[ "Insufficient_Enrollment" ]

false

true

false

Difficulty of realization of the study

[ "No_Context" ]

false

true

false

Difficulty recruiting

[ "Insufficient_Enrollment" ]

false

true

false

Difficulty recruiting (early discharge scheme initiated)

[ "Insufficient_Enrollment" ]

false

true

false

Difficulty recruiting eligible patients in timely fashion

[ "Insufficient_Enrollment" ]

false

true

false

Difficulty recruiting subjects

[ "Insufficient_Enrollment" ]

false

true

false

Difficulty recruiting subjects to dosing cohort 5.

[ "Insufficient_Enrollment", "Study_Design" ]

false

true

false

true

false

Difficulty to include patient

[ "Logistics_Resources", "Insufficient_Enrollment", "Study_Design" ]

false

true

false

true

false

true

false

Difficulty to include patients

[ "Insufficient_Enrollment" ]

false

true

false

Difficulty to keep children in randomly assigned groups.

[ "Study_Design" ]

false

true

false

Difficulty with accrual

[ "Insufficient_Enrollment" ]

false

true

false

Difficulty with enrollment

[ "Insufficient_Enrollment" ]

false

true

false

Dificulties in the recruitment of patients.

[ "Insufficient_Enrollment" ]

false

true

false

Discontinuation of program

[ "Business_Administrative", "No_Context" ]

false

true

false

true

false

Discontinuation of the development

[ "Logistics_Resources" ]

false

true

false

Discontinued PB127 development program for business reasons

[ "Business_Administrative" ]

false

true

false

Discontinued cystitis study due to poor recruitment. To continue the trial under theseÊ circumstances is considered non-viable.

[ "Insufficient_Enrollment" ]

false

true

false

Discontinued due to company's strategic reason

[ "Business_Administrative" ]

false

true

false

Discontinued due to incomplete recruitment

[ "Insufficient_Enrollment" ]

false

true

false

Discontinued due to non-enrollment.

[ "Insufficient_Enrollment" ]

false

true

false

Dissatisfactory enrollment rate

[ "Insufficient_Enrollment" ]

false

true

false

Dose levels were determined to be subtherapeutic

[ "Negative" ]

false

true

false

Dose limiting tox is observed. Study put on full clinical hold.

[ "Safety_Sideeffects" ]

false

true

false

Dose limiting toxicities on lowest dose level

[ "Safety_Sideeffects" ]

false

true

false

Dosing stopped

[ "No_Context" ]

false

true

false

Dr. Grose has left this practice, this study is terminated"

[ "Study_Staff_Moved" ]

false

true

false

Dr. Holguin is relocating.

[ "Study_Staff_Moved" ]

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

Dr. Milla has left University of Minnesota. The study is no longer being conducted at this site.

[ "Study_Staff_Moved" ]

false

true

false

Dr. Vindas completed his fellowship + low enrollment

[ "Insufficient_Enrollment" ]

false

true

false

Drug (Aflibercept) no longuer available for the study

[ "Logistics_Resources" ]

false

true

false

Drug Manufacturer withdrew support for studies not in metastatic breast cancer

[ "Business_Administrative", "Logistics_Resources" ]

false

true

false

true

false

Drug combination is no longer pursued

[ "Business_Administrative" ]

false

true

false