opentargets/clinical_trial_reason_to_stop

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
Commercial availability of Xenazine	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Commercial decision to discontinue the study	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Commercial reasons	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Company Decision	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Company business decision, IDE closed, no commercialization planned"	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Company closed May 1, 2019	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Company decision	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Company decision has been taken in light of recent demands by certain national health authorities	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Company decision not to pursue prior to submission	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Company decision taken in light of demands by certain national health authorities	[ "Business_Administrative", "Regulatory" ]	false	true	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false
Company decision to discontinue the AVE1642 development program, not due to any safety or efficacy concerns"	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Company decision to discontinue the study, not due to any safety or efficacy concerns	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Company decision to discontinue trial	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Company decision to halt study	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Company decision to not fund further development of women's health new drug development programs.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Company decision to withdraw product from the market and terminate development initiatives due to potential device failures.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Company decision.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Company decision. Non-safety related	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Company is closed	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Company restructured and protocol restructured. Resubmitted with IDE approval under new company name-Exalenz	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Company stopped production of study drug due to excessive toxicities, lack of efficacy	[ "Safety_Sideeffects", "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	true	false	false	false
Company strategic decision	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Company strategy	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Company suspended development of product.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Company terminated drug support	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Company went out of business	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Competing Departmental Studies	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Competing studies	[ "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Competing study at site	[ "Business_Administrative", "Another_Study" ]	true	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Competing study opened	[ "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Competing study was started.	[ "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Completed	[ "Invalid_Reason" ]	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false
Compound is not expected to change the current treatment practice or fill significant clinicalÊ need for patients in China over currently available EE agents.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Computers/hardware for data collection/storage are outdated and unserviceable.	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Concerns about safety at the first interim analysis	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
Concerns regarding neonatal data	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Concluded - Terminated by PI	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Consent form is being revised	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Consenting participants entered tenofovir/emtricitabine oral prophylaxis trial	[ "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Considered not necessary to continue with this trial; recommended dose was reached in other phase I trials	[ "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Context of the Covid-19 pandemic	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Contract Issues	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Contractual issues	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Coronary flow by echo Doppler was obtainable in about 50% of subjects. The study was stopped early because of insufficient sample size to achieve adequate power	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Coronavirus precautions, clinical research center closed	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Corporate decision	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Corporate decision to discontinue distribution of MJS Knee.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Corporate decision to reformulate the investigational product.	[ "Business_Administrative", "Study_Design" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Corporate re-prioritization	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Corporate reasons unrelated to safety and efficacy	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Corroboration of supporting in vitro data	[ "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Costs of study procedures has changed and escalated and became prohibitive.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Could not enroll enough participants, and lost funding.	[ "Logistics_Resources", "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	true	false	false	false	false	false	false	false
Could not enroll patients	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Could not find subject population	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Could not meet recruitment, technology advancement."	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Could not recruit	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Could not recruit any more people.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Covid 19 pandemic	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Covid-19	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Covid-19 pandemic	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Covid-19 pandÌ©mie	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Covid-19 resolution.	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Created Extension study	[ "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Created Extension study - This study was no longer feasible	[ "Study_Design", "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Cubist has reached an agreement with the FDA that enrollment in the DAP-RENSE-08-05 study canÊ stop.	[ "Regulatory" ]	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false
Current lack of medication support.	[ "Logistics_Resources", "Study_Design" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	true	false	false
Currently on partial clinical hold due to COVID-19 policies.	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Currently suspended due to COVID-19 policies	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Currently suspended due to COVID-19 policies.	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Currently suspended due to Covid-19 policies.	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Currently suspended due to covid-19 policies.	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Curretly suspended due to Covid-19 policies.	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
DSMB	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
DSMB felt continuing study will not yield any statistical significance.	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
DSMB recommendation for slow enrollment	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
DSMB recommended termination due to lower survival to discharge in primary population and worse discharge CPC scores in the treatment arm than control arm.	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
DSMB recommended termination due to lower survival to discharge in primary population and Ê worse discharge CPC scores in the treatment arm than control arm.	[ "Regulatory", "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	true	false	false	false	false
DSMB review at 50% recruitment, further recruitment unlikely to change result"	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
DSMB reviewed data of 1st 10 subjects; determined no safety concerns. Efficacy as a single agent in this patient population was unlikely. Voluntary Termination	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
DSMB stopped the study based on conclusion of likely futility of treatment on the primary outcome.	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
DSMB stopped trial for futility	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
DSMC acknowledged no safety concerns with the trial, recommending that the trial be terminated due to slow enrollment."	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
DSMC acknowledged no safety concerns with the trial, recommending that the trial be terminatedÊ due to slow enrollment	[ "Insufficient_Enrollment", "Study_Design" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	true	false	false
DSMC recommendation based on safety data	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
DSPD focussing on Study 301 to confirm clinical profile before proceeding.	[ "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Data Monitoring Committee cited poor accrual.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Data Monitoring Committee decision on 22nd August 2011 for safety issues	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
Data Safety Monitoring Committee decision	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Data inconclusive.	[ "Study_Design", "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	true	false	false
Data presented at SABCS 2010 showing that dual blockade is superior to monotherapy	[ "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Date of termination was Feb. 7, 2008. Reasons of termination were due to elevation of liver function tests and long elimination half-life of the compound."	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
Decided to conduct study in adults first	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Decision made by B&L to cancel the study, no subjects enrolled."	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Decision of the Sponsor, as the funding of the study was no longer guaranteed.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Decision of the Steering Committee. Recruitment more difficult and slower than expected.	[ "Business_Administrative", "Insufficient_Enrollment" ]	false	true	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Decision of the investigator	[ "No_Context" ]	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false
Decision to change trial design.	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Decision to discontinue due to challenges of trial design and constraints on enrolling eligibleÊ and consenting patients.	[ "Study_Design", "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	true	false	false
Decision to modify the product under study as a result of feedback regarding subjective feeling during installation procedure. For more info, see brief summary."	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false

Commercial availability of Xenazine

[ "Study_Design" ]

false

true

false

Commercial decision to discontinue the study

[ "Business_Administrative" ]

false

true

false

Commercial reasons

[ "Business_Administrative" ]

false

true

false

Company Decision

[ "Business_Administrative" ]

false

true

false

Company business decision, IDE closed, no commercialization planned"

[ "Business_Administrative" ]

false

true

false

Company closed May 1, 2019

[ "Business_Administrative" ]

false

true

false

Company decision

[ "Business_Administrative" ]

false

true

false

Company decision has been taken in light of recent demands by certain national health authorities

[ "Business_Administrative" ]

false

true

false

Company decision not to pursue prior to submission

[ "Business_Administrative" ]

false

true

false

Company decision taken in light of demands by certain national health authorities

[ "Business_Administrative", "Regulatory" ]

false

true

false

true

false

Company decision to discontinue the AVE1642 development program, not due to any safety or efficacy concerns"

[ "Business_Administrative" ]

false

true

false

Company decision to discontinue the study, not due to any safety or efficacy concerns

[ "Business_Administrative" ]

false

true

false

Company decision to discontinue trial

[ "Business_Administrative" ]

false

true

false

Company decision to halt study

[ "Business_Administrative" ]

false

true

false

Company decision to not fund further development of women's health new drug development programs.

[ "Business_Administrative" ]

false

true

false

Company decision to withdraw product from the market and terminate development initiatives due to potential device failures.

[ "Business_Administrative" ]

false

true

false

Company decision.

[ "Business_Administrative" ]

false

true

false

Company decision. Non-safety related

[ "Business_Administrative" ]

false

true

false

Company is closed

[ "Business_Administrative" ]

false

true

false

Company restructured and protocol restructured. Resubmitted with IDE approval under new company name-Exalenz

[ "Business_Administrative" ]

false

true

false

Company stopped production of study drug due to excessive toxicities, lack of efficacy

[ "Safety_Sideeffects", "Negative" ]

false

true

false

true

false

Company strategic decision

[ "Business_Administrative" ]

false

true

false

Company strategy

[ "Business_Administrative" ]

false

true

false

Company suspended development of product.

[ "Business_Administrative" ]

false

true

false

Company terminated drug support

[ "Business_Administrative" ]

false

true

false

Company went out of business

[ "Business_Administrative" ]

false

true

false

Competing Departmental Studies

[ "Business_Administrative" ]

false

true

false

Competing studies

[ "Another_Study" ]

true

false

Competing study at site

[ "Business_Administrative", "Another_Study" ]

true

false

Competing study opened

[ "Another_Study" ]

true

false

Competing study was started.

[ "Another_Study" ]

true

false

Completed

[ "Invalid_Reason" ]

false

true

false

Compound is not expected to change the current treatment practice or fill significant clinicalÊ need for patients in China over currently available EE agents.

[ "Business_Administrative" ]

false

true

false

Computers/hardware for data collection/storage are outdated and unserviceable.

[ "Logistics_Resources" ]

false

true

false

Concerns about safety at the first interim analysis

[ "Safety_Sideeffects" ]

false

true

false

Concerns regarding neonatal data

[ "Negative" ]

false

true

false

Concluded - Terminated by PI

[ "Business_Administrative" ]

false

true

false

Consent form is being revised

[ "Study_Design" ]

false

true

false

Consenting participants entered tenofovir/emtricitabine oral prophylaxis trial

[ "Another_Study" ]

true

false

Considered not necessary to continue with this trial; recommended dose was reached in other phase I trials

[ "Another_Study" ]

true

false

Context of the Covid-19 pandemic

[ "Covid19" ]

false

true

false

Contract Issues

[ "Business_Administrative" ]

false

true

false

Contractual issues

[ "Business_Administrative" ]

false

true

false

Coronary flow by echo Doppler was obtainable in about 50% of subjects. The study was stopped early because of insufficient sample size to achieve adequate power

[ "Negative" ]

false

true

false

Coronavirus precautions, clinical research center closed

[ "Covid19" ]

false

true

false

Corporate decision

[ "Business_Administrative" ]

false

true

false

Corporate decision to discontinue distribution of MJS Knee.

[ "Business_Administrative" ]

false

true

false

Corporate decision to reformulate the investigational product.

[ "Business_Administrative", "Study_Design" ]

false

true

false

true

false

Corporate re-prioritization

[ "Business_Administrative" ]

false

true

false

Corporate reasons unrelated to safety and efficacy

[ "Business_Administrative" ]

false

true

false

Corroboration of supporting in vitro data

[ "Another_Study" ]

true

false

Costs of study procedures has changed and escalated and became prohibitive.

[ "Business_Administrative" ]

false

true

false

Could not enroll enough participants, and lost funding.

[ "Logistics_Resources", "Insufficient_Enrollment" ]

false

true

false

true

false

Could not enroll patients

[ "Insufficient_Enrollment" ]

false

true

false

Could not find subject population

[ "Insufficient_Enrollment" ]

false

true

false

Could not meet recruitment, technology advancement."

[ "Study_Design" ]

false

true

false

Could not recruit

[ "Insufficient_Enrollment" ]

false

true

false

Could not recruit any more people.

[ "Insufficient_Enrollment" ]

false

true

false

Covid 19 pandemic

[ "Covid19" ]

false

true

false

Covid-19

[ "Covid19" ]

false

true

false

Covid-19 pandemic

[ "Covid19" ]

false

true

false

Covid-19 pandÌ©mie

[ "Covid19" ]

false

true

false

Covid-19 resolution.

[ "Covid19" ]

false

true

false

Created Extension study

[ "Another_Study" ]

true

false

Created Extension study - This study was no longer feasible

[ "Study_Design", "Another_Study" ]

true

false

true

false

Cubist has reached an agreement with the FDA that enrollment in the DAP-RENSE-08-05 study canÊ stop.

[ "Regulatory" ]

false

true

false

Current lack of medication support.

[ "Logistics_Resources", "Study_Design" ]

false

true

false

true

false

Currently on partial clinical hold due to COVID-19 policies.

[ "Covid19" ]

false

true

false

Currently suspended due to COVID-19 policies

[ "Covid19" ]

false

true

false

Currently suspended due to COVID-19 policies.

[ "Covid19" ]

false

true

false

Currently suspended due to Covid-19 policies.

[ "Covid19" ]

false

true

false

Currently suspended due to covid-19 policies.

[ "Covid19" ]

false

true

false

Curretly suspended due to Covid-19 policies.

[ "Covid19" ]

false

true

false

DSMB

[ "Negative" ]

false

true

false

DSMB felt continuing study will not yield any statistical significance.

[ "Negative" ]

false

true

false

DSMB recommendation for slow enrollment

[ "Insufficient_Enrollment" ]

false

true

false

DSMB recommended termination due to lower survival to discharge in primary population and worse discharge CPC scores in the treatment arm than control arm.

[ "Negative" ]

false

true

false

DSMB recommended termination due to lower survival to discharge in primary population and Ê worse discharge CPC scores in the treatment arm than control arm.

[ "Regulatory", "Negative" ]

false

true

false

true

false

DSMB review at 50% recruitment, further recruitment unlikely to change result"

[ "Negative" ]

false

true

false

DSMB reviewed data of 1st 10 subjects; determined no safety concerns. Efficacy as a single agent in this patient population was unlikely. Voluntary Termination

[ "Negative" ]

false

true

false

DSMB stopped the study based on conclusion of likely futility of treatment on the primary outcome.

[ "Negative" ]

false

true

false

DSMB stopped trial for futility

[ "Negative" ]

false

true

false

DSMC acknowledged no safety concerns with the trial, recommending that the trial be terminated due to slow enrollment."

[ "Insufficient_Enrollment" ]

false

true

false

DSMC acknowledged no safety concerns with the trial, recommending that the trial be terminatedÊ due to slow enrollment

[ "Insufficient_Enrollment", "Study_Design" ]

false

true

false

true

false

DSMC recommendation based on safety data

[ "Safety_Sideeffects" ]

false

true

false

DSPD focussing on Study 301 to confirm clinical profile before proceeding.

[ "Another_Study" ]

true

false

Data Monitoring Committee cited poor accrual.

[ "Insufficient_Enrollment" ]

false

true

false

Data Monitoring Committee decision on 22nd August 2011 for safety issues

[ "Safety_Sideeffects" ]

false

true

false

Data Safety Monitoring Committee decision

[ "Negative" ]

false

true

false

Data inconclusive.

[ "Study_Design", "Negative" ]

false

true

false

true

false

Data presented at SABCS 2010 showing that dual blockade is superior to monotherapy

[ "Another_Study" ]

true

false

Date of termination was Feb. 7, 2008. Reasons of termination were due to elevation of liver function tests and long elimination half-life of the compound."

[ "Safety_Sideeffects" ]

false

true

false

Decided to conduct study in adults first

[ "Study_Design" ]

false

true

false

Decision made by B&L to cancel the study, no subjects enrolled."

[ "Business_Administrative" ]

false

true

false

Decision of the Sponsor, as the funding of the study was no longer guaranteed.

[ "Business_Administrative" ]

false

true

false

Decision of the Steering Committee. Recruitment more difficult and slower than expected.

[ "Business_Administrative", "Insufficient_Enrollment" ]

false

true

false

true

false

Decision of the investigator

[ "No_Context" ]

false

true

false

Decision to change trial design.

[ "Study_Design" ]

false

true

false

Decision to discontinue due to challenges of trial design and constraints on enrolling eligibleÊ and consenting patients.

[ "Study_Design", "Insufficient_Enrollment" ]

false

true

false

true

false

Decision to modify the product under study as a result of feedback regarding subjective feeling during installation procedure. For more info, see brief summary."

[ "Study_Design" ]

false

true

false