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
Large sample size and change in Orthopaedic practice to use of CCPM in conjunction with Clinical Monitoring rendered project less timely.	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Last patient left the study after the last visit	[ "Invalid_Reason" ]	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false
Last subject enrolled experienced bradycardia; study was terminated by Sponsor.	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
Last subject out	[ "Invalid_Reason" ]	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false
Lead was recalled and manufacturing halted	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Leaving of the person responsible for the data collection	[ "Study_Staff_Moved" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false
Limitation of funding	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Limited beta-blocker naive participants among newly diagnosed heart failure participants, whichÊ led barrier to the recruitments.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Limited budget to continue this study	[ "Logistics_Resources", "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Limited number of subjects	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Limited numbers of patients qualified for trial	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Limited regulatory value to uncontrolled trials. No safety/efficacy concerns.	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Limited resources	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Local IRB decision due to poor accrual	[ "Insufficient_Enrollment", "Study_Design", "Regulatory" ]	false	false	false	false	false	false	true	false	false	false	false	false	true	false	true	false	false
Local pharmacy unwilling to comply with study protocol	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Logistic problems with adequately timely organ collection and transport	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Logistic reasons (insufficient funding, technical problems with MEMS)	[ "Logistics_Resources", "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Logistical difficulties running the study	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Logistical reasons	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Logistics failure and staff/scanner shortage	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Loss of Research Data	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Loss of funding	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Loss of funding from sponsor	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Loss of study staff	[ "Study_Staff_Moved" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false
Lost funding	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Lost funding; Shriner Burn Hosp has revoked access to study records. No updates or results canÊ be submitted	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Low Accrual	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low Accrual, Funding	[ "Business_Administrative", "Insufficient_Enrollment" ]	false	true	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low Accrual, Funding"	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low Accural	[ "Logistics_Resources", "Business_Administrative", "Insufficient_Enrollment" ]	false	true	false	false	false	false	true	false	false	true	false	false	false	false	false	false	false
Low Enrollment	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low Recruitment	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low accrual	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low accrual and loss of funding	[ "Business_Administrative", "Logistics_Resources" ]	false	true	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Low accrual and loss of funding.	[ "Business_Administrative", "Insufficient_Enrollment", "Insufficient_Data" ]	false	true	false	false	false	true	true	false	false	false	false	false	false	false	false	false	false
Low accrual not allowing site to meeting statistical endpoints	[ "Logistics_Resources", "Insufficient_Enrollment", "Insufficient_Data" ]	false	false	false	false	false	true	true	false	false	true	false	false	false	false	false	false	false
Low accrual rate	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low accrual rate.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low accrual, no adverse events."	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low accrual, study terminated."	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low accrual.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low accruals	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low accrural	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low acrual	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low cure rate in the study (fluconazole) group	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Low enroll rate	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low enrollment	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low enrollment due to the stringent enrollment criteria. Unable to answer study questions	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low enrollment rate	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low enrollment rates	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low feasibility	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Low inclusion rate	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low levels of recruitment	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low likelihood of identifying a statistically significant treatment effect.	[ "Study_Design", "Insufficient_Data" ]	false	false	false	false	false	true	false	false	false	false	false	false	false	false	true	false	false
Low overall response rate	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low participant accrual	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low participant accrual.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low patient accrual	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low patient enrollment; toxicities	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low probability of positive outcome	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Low rate of enrollment	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low rate of patient recruitment; low likelihood of achieving the sample size in a reasonable time frame. No safety concerns.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low rate of subject accrual	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low recruitement rate	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low recruitment	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low recruitment due to change in standard of care	[ "Insufficient_Enrollment", "Study_Design" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	true	false	false
Low recruitment rate	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low recruitment rate due to treatment regimen change	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Low recruitment rate. In our center, open radical prostatectomies have been almost completelyÊ replaced by robotic prostatectomies.	[ "Insufficient_Enrollment", "Study_Design" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	true	false	false
Low recruitment rate. with the final sample primary endpoint could be assessed.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low recruitment status	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low recruitment.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low response	[ "No_Context" ]	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false
Low study accrual	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low study enrollment	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low study enrollment; re-evaluating study protocol and study selection criteria.	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Low study participant enrollment.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low/no enrollment. No subjects were enrolled over the past year.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Low/slow accrual	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Lower than anticipated recruitment	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Lucentis, a treatment superior to PDT, has become available i Sweden.	[ "Another_Study", "Negative" ]	true	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Lucentis, a treatment superior to PDT, has become available i Sweden."	[ "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
MI-CP177 study closed per sponsor decision.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
MTD determined	[ "No_Context" ]	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false
Main objective of study was met. Further recruitment was difficult.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Main reason: negative echo in the literature after the first publications.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Major amendments in progress	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Major difficulties recruiting participants	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Major planned study protocol modifications	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Major side-effects	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
Making amendments to the study	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Malaria prev. fell in the study area, so we cannot evaluate the primary endpoint"	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Management Decision	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Management decision not to conduct an additional efficacy study.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Manufacturer changed device so no study will be done; ie it was never started	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Manufacturer stopped drug development	[ "Business_Administrative", "Logistics_Resources" ]	false	true	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Manufacturing change in one of the two lipid emulsion products being studied.	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Manufacturing stopped	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Market dynamics including other technologies made the project not viable.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
May continue recruiting only if required by journal reviewers	[ "Invalid_Reason" ]	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false

Large sample size and change in Orthopaedic practice to use of CCPM in conjunction with Clinical Monitoring rendered project less timely.

[ "Study_Design" ]

false

true

false

Last patient left the study after the last visit

[ "Invalid_Reason" ]

false

true

false

Last subject enrolled experienced bradycardia; study was terminated by Sponsor.

[ "Safety_Sideeffects" ]

false

true

false

Last subject out

[ "Invalid_Reason" ]

false

true

false

Lead was recalled and manufacturing halted

[ "Logistics_Resources" ]

false

true

false

Leaving of the person responsible for the data collection

[ "Study_Staff_Moved" ]

false

true

false

Limitation of funding

[ "Business_Administrative" ]

false

true

false

Limited beta-blocker naive participants among newly diagnosed heart failure participants, whichÊ led barrier to the recruitments.

[ "Insufficient_Enrollment" ]

false

true

false

Limited budget to continue this study

[ "Logistics_Resources", "Business_Administrative" ]

false

true

false

true

false

Limited number of subjects

[ "Insufficient_Enrollment" ]

false

true

false

Limited numbers of patients qualified for trial

[ "Insufficient_Enrollment" ]

false

true

false

Limited regulatory value to uncontrolled trials. No safety/efficacy concerns.

[ "Study_Design" ]

false

true

false

Limited resources

[ "Logistics_Resources" ]

false

true

false

Local IRB decision due to poor accrual

[ "Insufficient_Enrollment", "Study_Design", "Regulatory" ]

false

true

false

true

false

true

false

Local pharmacy unwilling to comply with study protocol

[ "Study_Design" ]

false

true

false

Logistic problems with adequately timely organ collection and transport

[ "Logistics_Resources" ]

false

true

false

Logistic reasons (insufficient funding, technical problems with MEMS)

[ "Logistics_Resources", "Business_Administrative" ]

false

true

false

true

false

Logistical difficulties running the study

[ "Logistics_Resources" ]

false

true

false

Logistical reasons

[ "Logistics_Resources" ]

false

true

false

Logistics failure and staff/scanner shortage

[ "Logistics_Resources" ]

false

true

false

Loss of Research Data

[ "Logistics_Resources" ]

false

true

false

Loss of funding

[ "Business_Administrative" ]

false

true

false

Loss of funding from sponsor

[ "Business_Administrative" ]

false

true

false

Loss of study staff

[ "Study_Staff_Moved" ]

false

true

false

Lost funding

[ "Business_Administrative" ]

false

true

false

Lost funding; Shriner Burn Hosp has revoked access to study records. No updates or results canÊ be submitted

[ "Business_Administrative" ]

false

true

false

Low Accrual

[ "Insufficient_Enrollment" ]

false

true

false

Low Accrual, Funding

[ "Business_Administrative", "Insufficient_Enrollment" ]

false

true

false

true

false

Low Accrual, Funding"

[ "Insufficient_Enrollment" ]

false

true

false

Low Accural

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

false

true

false

true

false

true

false

Low Enrollment

[ "Insufficient_Enrollment" ]

false

true

false

Low Recruitment

[ "Insufficient_Enrollment" ]

false

true

false

Low accrual

[ "Insufficient_Enrollment" ]

false

true

false

Low accrual and loss of funding

[ "Business_Administrative", "Logistics_Resources" ]

false

true

false

true

false

Low accrual and loss of funding.

[ "Business_Administrative", "Insufficient_Enrollment", "Insufficient_Data" ]

false

true

false

true

false

Low accrual not allowing site to meeting statistical endpoints

[ "Logistics_Resources", "Insufficient_Enrollment", "Insufficient_Data" ]

false

true

false

true

false

Low accrual rate

[ "Insufficient_Enrollment" ]

false

true

false

Low accrual rate.

[ "Insufficient_Enrollment" ]

false

true

false

Low accrual, no adverse events."

[ "Insufficient_Enrollment" ]

false

true

false

Low accrual, study terminated."

[ "Insufficient_Enrollment" ]

false

true

false

Low accrual.

[ "Insufficient_Enrollment" ]

false

true

false

Low accruals

[ "Insufficient_Enrollment" ]

false

true

false

Low accrural

[ "Insufficient_Enrollment" ]

false

true

false

Low acrual

[ "Insufficient_Enrollment" ]

false

true

false

Low cure rate in the study (fluconazole) group

[ "Negative" ]

false

true

false

Low enroll rate

[ "Insufficient_Enrollment" ]

false

true

false

Low enrollment

[ "Insufficient_Enrollment" ]

false

true

false

Low enrollment due to the stringent enrollment criteria. Unable to answer study questions

[ "Insufficient_Enrollment" ]

false

true

false

Low enrollment rate

[ "Insufficient_Enrollment" ]

false

true

false

Low enrollment rates

[ "Insufficient_Enrollment" ]

false

true

false

Low feasibility

[ "Negative" ]

false

true

false

Low inclusion rate

[ "Insufficient_Enrollment" ]

false

true

false

Low levels of recruitment

[ "Insufficient_Enrollment" ]

false

true

false

Low likelihood of identifying a statistically significant treatment effect.

[ "Study_Design", "Insufficient_Data" ]

false

true

false

true

false

Low overall response rate

[ "Insufficient_Enrollment" ]

false

true

false

Low participant accrual

[ "Insufficient_Enrollment" ]

false

true

false

Low participant accrual.

[ "Insufficient_Enrollment" ]

false

true

false

Low patient accrual

[ "Insufficient_Enrollment" ]

false

true

false

Low patient enrollment; toxicities

[ "Insufficient_Enrollment" ]

false

true

false

Low probability of positive outcome

[ "Negative" ]

false

true

false

Low rate of enrollment

[ "Insufficient_Enrollment" ]

false

true

false

Low rate of patient recruitment; low likelihood of achieving the sample size in a reasonable time frame. No safety concerns.

[ "Insufficient_Enrollment" ]

false

true

false

Low rate of subject accrual

[ "Insufficient_Enrollment" ]

false

true

false

Low recruitement rate

[ "Insufficient_Enrollment" ]

false

true

false

Low recruitment

[ "Insufficient_Enrollment" ]

false

true

false

Low recruitment due to change in standard of care

[ "Insufficient_Enrollment", "Study_Design" ]

false

true

false

true

false

Low recruitment rate

[ "Insufficient_Enrollment" ]

false

true

false

Low recruitment rate due to treatment regimen change

[ "Study_Design" ]

false

true

false

Low recruitment rate. In our center, open radical prostatectomies have been almost completelyÊ replaced by robotic prostatectomies.

[ "Insufficient_Enrollment", "Study_Design" ]

false

true

false

true

false

Low recruitment rate. with the final sample primary endpoint could be assessed.

[ "Insufficient_Enrollment" ]

false

true

false

Low recruitment status

[ "Insufficient_Enrollment" ]

false

true

false

Low recruitment.

[ "Insufficient_Enrollment" ]

false

true

false

Low response

[ "No_Context" ]

false

true

false

Low study accrual

[ "Insufficient_Enrollment" ]

false

true

false

Low study enrollment

[ "Insufficient_Enrollment" ]

false

true

false

Low study enrollment; re-evaluating study protocol and study selection criteria.

[ "Study_Design" ]

false

true

false

Low study participant enrollment.

[ "Insufficient_Enrollment" ]

false

true

false

Low/no enrollment. No subjects were enrolled over the past year.

[ "Insufficient_Enrollment" ]

false

true

false

Low/slow accrual

[ "Insufficient_Enrollment" ]

false

true

false

Lower than anticipated recruitment

[ "Insufficient_Enrollment" ]

false

true

false

Lucentis, a treatment superior to PDT, has become available i Sweden.

[ "Another_Study", "Negative" ]

true

false

true

false

Lucentis, a treatment superior to PDT, has become available i Sweden."

[ "Another_Study" ]

true

false

MI-CP177 study closed per sponsor decision.

[ "Business_Administrative" ]

false

true

false

MTD determined

[ "No_Context" ]

false

true

false

Main objective of study was met. Further recruitment was difficult.

[ "Insufficient_Enrollment" ]

false

true

false

Main reason: negative echo in the literature after the first publications.

[ "Business_Administrative" ]

false

true

false

Major amendments in progress

[ "Study_Design" ]

false

true

false

Major difficulties recruiting participants

[ "Insufficient_Enrollment" ]

false

true

false

Major planned study protocol modifications

[ "Study_Design" ]

false

true

false

Major side-effects

[ "Safety_Sideeffects" ]

false

true

false

Making amendments to the study

[ "Study_Design" ]

false

true

false

Malaria prev. fell in the study area, so we cannot evaluate the primary endpoint"

[ "Logistics_Resources" ]

false

true

false

Management Decision

[ "Business_Administrative" ]

false

true

false

Management decision not to conduct an additional efficacy study.

[ "Business_Administrative" ]

false

true

false

Manufacturer changed device so no study will be done; ie it was never started

[ "Study_Design" ]

false

true

false

Manufacturer stopped drug development

[ "Business_Administrative", "Logistics_Resources" ]

false

true

false

true

false

Manufacturing change in one of the two lipid emulsion products being studied.

[ "Study_Design" ]

false

true

false

Manufacturing stopped

[ "Logistics_Resources" ]

false

true

false

Market dynamics including other technologies made the project not viable.

[ "Business_Administrative" ]

false

true

false

May continue recruiting only if required by journal reviewers

[ "Invalid_Reason" ]

false

true

false