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
Follow up only	[ "Invalid_Reason" ]	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false
Follow-up end in 1999	[ "Invalid_Reason" ]	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false
Following Regulator inspection in 2009, study terminated as inadequate approvals were in place	[ "Regulatory" ]	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false
Following a pre-specified interim analysis and Data Monitoring Committee recommendation due to insufficient level of efficacy	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Following a pre-specified interim analysis and Data Monitoring Committee recommendation due toÊ insufficient level of efficacy	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Following an SAE, study was put on hold. After performing preclinical follow-up studies, volunteers were no longer available for continuation."	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies.	[ "Business_Administrative", "Another_Study" ]	true	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Following the recall of Ionsys, the study has been stopped. Data analysis will be undertaken in accordance with the Analysis Plan."	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
Following the termination of development and commercialization agreement for S-1 with Taiho Pharmaceutical	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
For Strategic Reasons	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
For business reasons	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
For financial and logistical reasons	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
For safety reasons the recruitment was halted prematurely. Patients on the trial continute to Ê receive treatment and are being followed up as part the protocol.	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
Formulation issues.	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
From Sept./08 to April/09 only 30 subjects were recruited. It has proved extremely difficult to recruit subjects.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Full Clinical Hold	[ "Business_Administrative", "Invalid_Reason" ]	false	true	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false
Funder withdrawn funding.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funders withdrew funding due to slow recruitment	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding	[ "Business_Administrative", "Logistics_Resources" ]	false	true	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Funding Discontinued	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding Period Ended	[ "Business_Administrative", "Logistics_Resources" ]	false	true	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Funding agent withdrew funding	[ "Business_Administrative", "Logistics_Resources" ]	false	true	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Funding allocation to different clinical trials.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding and manpower for this study was unavailable, and completion within a reasonableÊ timeframe was not possible.	[ "Business_Administrative", "Logistics_Resources", "Study_Design" ]	false	true	false	false	false	false	false	false	false	true	false	false	false	false	true	false	false
Funding and study drugs unavailable	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding associated with enrollment milestones was withdrawn by Sponsor.	[ "Logistics_Resources", "Business_Administrative", "Insufficient_Enrollment" ]	false	true	false	false	false	false	true	false	false	true	false	false	false	false	false	false	false
Funding completed	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding constraints	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding ended	[ "Business_Administrative", "Logistics_Resources" ]	false	true	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Funding ended for the study	[ "Business_Administrative", "Logistics_Resources" ]	false	true	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Funding expired	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding expired, low recruitment	[ "Logistics_Resources", "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	true	false	false	false	false	false	false	false
Funding expired, low recruitment"	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding for continuation was not received.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding for the CALM-PD Cohort Study was terminated by sponsor.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding has been pulled	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding issue	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding issues	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding issues.	[ "Business_Administrative", "Logistics_Resources" ]	false	true	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Funding limits exceeded prior to complete enrollment.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding nonavailability and principal investigator move	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding not available	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding not available, PI left institution	[ "Business_Administrative", "Study_Staff_Moved" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false
Funding not available, study did not open to accrual and will not open in future	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding not available. Could not start this study.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding not obtained	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding not received	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding problem.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding problem; trial abandoned.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding ran out	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding support withdrawn	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding term completed. Final subject accrual for part 3 of study is on hold.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding terminated	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding unavailable	[ "Business_Administrative", "Logistics_Resources", "Invalid_Reason" ]	false	true	false	false	false	false	false	false	true	true	false	false	false	false	false	false	false
Funding unavailable at this time for this particular study.	[ "Business_Administrative", "Logistics_Resources" ]	false	true	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Funding was inadequate to continue; Companies requested closure.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding was never granted for this study. No participants were ever enrolled.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding was never received so no patients were enrolled.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding was not acquired	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding was not approved	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding was not recieved	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding was terminated	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding was unable to be secured for this study	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding was unavailable to complete the study as originally planned.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding was withdrawn from Drug company	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding will not be provided for the drug	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding withdrawn	[ "Business_Administrative", "Logistics_Resources" ]	false	true	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Funding withdrawn due to low enrollment	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding withdrawn from study sponsor.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funding withdrawn; study closed due to lack of accrual.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funds for study ended September 30, 2008."	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Funds for this project have been spent, and it is thereby terminated."	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Further development of this compound with ipilimumab in the treatment of melanoma is no longerÊ being pursued.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Further evaluation determined it was not feasible to enroll the post-partum tubal ligation group at our facility	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Further evaluation of pharmacokinetic data in the target population is ongoing	[ "Interim_Analysis" ]	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false
Further evaluation of phase I dosing	[ "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Further recruitment into the study was ceased on 10th December 2009, not attributed to safety. All patients recruited in the study completed all study visits."	[ "Invalid_Reason" ]	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false
Further recruitment terminated after CE mark attained; enclosed patients will be followed up Ê to 5 years	[ "Success" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true
Futility	[ "No_Context", "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	true	false	false	false	false	false
Futility analysis failed to showed likelihoo of benefit of CoQ 2400 mg/day.	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Futility analysis undertaken, determined that study was underpowered.	[ "Insufficient_Enrollment", "Study_Design" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	true	false	false
Futility analysis undertaken, determined that study was underpowered."	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Futility boundary at interim analysis not met	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Futility in enrollment as of May 31, 2011	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Futility reasons after Independent Data Monitoring Committee interim analysis	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Future development of AZD1236 is currently under review by the project team and no new studies will be started until this review is completed.	[ "Interim_Analysis" ]	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false
GSK decision	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
GanLee cancelled study -FDA Draft Guidance: "Clinical Immunogenicity Considerations forÊ Biosimilar & Interchangeable Insulin Products" released 11/25/2019	[ "Safety_Sideeffects", "Regulatory" ]	false	false	false	false	false	false	false	false	false	false	false	false	true	true	false	false	false
GeneSearch_ BLN Assay has been voluntarily withdrawn from the US market.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Given the number of toxicities seen and the difficulty with patient retention in the doseÊ escalation portion, the sponsor decided to close the trial.	[ "Business_Administrative", "Safety_Sideeffects" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
Gm test became routinely available. We could not compare the two arms anymore.	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Grant application was not funded	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Grant expired	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Greater differences between randomized patients than previously anticipated	[ "Study_Design", "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	true	false	false
Had been finished	[ "No_Context" ]	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false
Halted by NICHD after recommendation by DSMC to stop for futility	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Halted prematurely due to low enrollment	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Halted prematurely due to slow accrual	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
HandyLab device determined to not work for the science	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
HandyLab device did not work for the science	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false

Follow up only

[ "Invalid_Reason" ]

false

true

false

Follow-up end in 1999

[ "Invalid_Reason" ]

false

true

false

Following Regulator inspection in 2009, study terminated as inadequate approvals were in place

[ "Regulatory" ]

false

true

false

Following a pre-specified interim analysis and Data Monitoring Committee recommendation due to insufficient level of efficacy

[ "Negative" ]

false

true

false

Following a pre-specified interim analysis and Data Monitoring Committee recommendation due toÊ insufficient level of efficacy

[ "Negative" ]

false

true

false

Following an SAE, study was put on hold. After performing preclinical follow-up studies, volunteers were no longer available for continuation."

[ "Insufficient_Enrollment" ]

false

true

false

Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies.

[ "Business_Administrative", "Another_Study" ]

true

false

Following the recall of Ionsys, the study has been stopped. Data analysis will be undertaken in accordance with the Analysis Plan."

[ "Safety_Sideeffects" ]

false

true

false

Following the termination of development and commercialization agreement for S-1 with Taiho Pharmaceutical

[ "Business_Administrative" ]

false

true

false

For Strategic Reasons

[ "Business_Administrative" ]

false

true

false

For business reasons

[ "Business_Administrative" ]

false

true

false

For financial and logistical reasons

[ "Business_Administrative" ]

false

true

false

For safety reasons the recruitment was halted prematurely. Patients on the trial continute to Ê receive treatment and are being followed up as part the protocol.

[ "Safety_Sideeffects" ]

false

true

false

Formulation issues.

[ "Logistics_Resources" ]

false

true

false

From Sept./08 to April/09 only 30 subjects were recruited. It has proved extremely difficult to recruit subjects.

[ "Insufficient_Enrollment" ]

false

true

false

Full Clinical Hold

[ "Business_Administrative", "Invalid_Reason" ]

false

true

false

true

false

Funder withdrawn funding.

[ "Business_Administrative" ]

false

true

false

Funders withdrew funding due to slow recruitment

[ "Business_Administrative" ]

false

true

false

Funding

[ "Business_Administrative", "Logistics_Resources" ]

false

true

false

true

false

Funding Discontinued

[ "Business_Administrative" ]

false

true

false

Funding Period Ended

[ "Business_Administrative", "Logistics_Resources" ]

false

true

false

true

false

Funding agent withdrew funding

[ "Business_Administrative", "Logistics_Resources" ]

false

true

false

true

false

Funding allocation to different clinical trials.

[ "Business_Administrative" ]

false

true

false

Funding and manpower for this study was unavailable, and completion within a reasonableÊ timeframe was not possible.

[ "Business_Administrative", "Logistics_Resources", "Study_Design" ]

false

true

false

true

false

true

false

Funding and study drugs unavailable

[ "Business_Administrative" ]

false

true

false

Funding associated with enrollment milestones was withdrawn by Sponsor.

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

false

true

false

true

false

true

false

Funding completed

[ "Business_Administrative" ]

false

true

false

Funding constraints

[ "Business_Administrative" ]

false

true

false

Funding ended

[ "Business_Administrative", "Logistics_Resources" ]

false

true

false

true

false

Funding ended for the study

[ "Business_Administrative", "Logistics_Resources" ]

false

true

false

true

false

Funding expired

[ "Business_Administrative" ]

false

true

false

Funding expired, low recruitment

[ "Logistics_Resources", "Insufficient_Enrollment" ]

false

true

false

true

false

Funding expired, low recruitment"

[ "Business_Administrative" ]

false

true

false

Funding for continuation was not received.

[ "Business_Administrative" ]

false

true

false

Funding for the CALM-PD Cohort Study was terminated by sponsor.

[ "Business_Administrative" ]

false

true

false

Funding has been pulled

[ "Business_Administrative" ]

false

true

false

Funding issue

[ "Business_Administrative" ]

false

true

false

Funding issues

[ "Business_Administrative" ]

false

true

false

Funding issues.

[ "Business_Administrative", "Logistics_Resources" ]

false

true

false

true

false

Funding limits exceeded prior to complete enrollment.

[ "Business_Administrative" ]

false

true

false

Funding nonavailability and principal investigator move

[ "Business_Administrative" ]

false

true

false

Funding not available

[ "Business_Administrative" ]

false

true

false

Funding not available, PI left institution

[ "Business_Administrative", "Study_Staff_Moved" ]

false

true

false

true

false

Funding not available, study did not open to accrual and will not open in future

[ "Business_Administrative" ]

false

true

false

Funding not available. Could not start this study.

[ "Business_Administrative" ]

false

true

false

Funding not obtained

[ "Business_Administrative" ]

false

true

false

Funding not received

[ "Business_Administrative" ]

false

true

false

Funding problem.

[ "Business_Administrative" ]

false

true

false

Funding problem; trial abandoned.

[ "Business_Administrative" ]

false

true

false

Funding ran out

[ "Business_Administrative" ]

false

true

false

Funding support withdrawn

[ "Business_Administrative" ]

false

true

false

Funding term completed. Final subject accrual for part 3 of study is on hold.

[ "Business_Administrative" ]

false

true

false

Funding terminated

[ "Business_Administrative" ]

false

true

false

Funding unavailable

[ "Business_Administrative", "Logistics_Resources", "Invalid_Reason" ]

false

true

false

true

false

Funding unavailable at this time for this particular study.

[ "Business_Administrative", "Logistics_Resources" ]

false

true

false

true

false

Funding was inadequate to continue; Companies requested closure.

[ "Business_Administrative" ]

false

true

false

Funding was never granted for this study. No participants were ever enrolled.

[ "Business_Administrative" ]

false

true

false

Funding was never received so no patients were enrolled.

[ "Business_Administrative" ]

false

true

false

Funding was not acquired

[ "Business_Administrative" ]

false

true

false

Funding was not approved

[ "Business_Administrative" ]

false

true

false

Funding was not recieved

[ "Business_Administrative" ]

false

true

false

Funding was terminated

[ "Business_Administrative" ]

false

true

false

Funding was unable to be secured for this study

[ "Business_Administrative" ]

false

true

false

Funding was unavailable to complete the study as originally planned.

[ "Business_Administrative" ]

false

true

false

Funding was withdrawn from Drug company

[ "Business_Administrative" ]

false

true

false

Funding will not be provided for the drug

[ "Business_Administrative" ]

false

true

false

Funding withdrawn

[ "Business_Administrative", "Logistics_Resources" ]

false

true

false

true

false

Funding withdrawn due to low enrollment

[ "Business_Administrative" ]

false

true

false

Funding withdrawn from study sponsor.

[ "Business_Administrative" ]

false

true

false

Funding withdrawn; study closed due to lack of accrual.

[ "Business_Administrative" ]

false

true

false

Funds for study ended September 30, 2008."

[ "Business_Administrative" ]

false

true

false

Funds for this project have been spent, and it is thereby terminated."

[ "Business_Administrative" ]

false

true

false

Further development of this compound with ipilimumab in the treatment of melanoma is no longerÊ being pursued.

[ "Business_Administrative" ]

false

true

false

Further evaluation determined it was not feasible to enroll the post-partum tubal ligation group at our facility

[ "Insufficient_Enrollment" ]

false

true

false

Further evaluation of pharmacokinetic data in the target population is ongoing

[ "Interim_Analysis" ]

false

true

false

Further evaluation of phase I dosing

[ "Another_Study" ]

true

false

Further recruitment into the study was ceased on 10th December 2009, not attributed to safety. All patients recruited in the study completed all study visits."

[ "Invalid_Reason" ]

false

true

false

Further recruitment terminated after CE mark attained; enclosed patients will be followed up Ê to 5 years

[ "Success" ]

false

true

Futility

[ "No_Context", "Negative" ]

false

true

false

Futility analysis failed to showed likelihoo of benefit of CoQ 2400 mg/day.

[ "Negative" ]

false

true

false

Futility analysis undertaken, determined that study was underpowered.

[ "Insufficient_Enrollment", "Study_Design" ]

false

true

false

true

false

Futility analysis undertaken, determined that study was underpowered."

[ "Negative" ]

false

true

false

Futility boundary at interim analysis not met

[ "Negative" ]

false

true

false

Futility in enrollment as of May 31, 2011

[ "Insufficient_Enrollment" ]

false

true

false

Futility reasons after Independent Data Monitoring Committee interim analysis

[ "Negative" ]

false

true

false

Future development of AZD1236 is currently under review by the project team and no new studies will be started until this review is completed.

[ "Interim_Analysis" ]

false

true

false

GSK decision

[ "Business_Administrative" ]

false

true

false

GanLee cancelled study -FDA Draft Guidance: "Clinical Immunogenicity Considerations forÊ Biosimilar & Interchangeable Insulin Products" released 11/25/2019

[ "Safety_Sideeffects", "Regulatory" ]

false

true

false

GeneSearch_ BLN Assay has been voluntarily withdrawn from the US market.

[ "Business_Administrative" ]

false

true

false

Given the number of toxicities seen and the difficulty with patient retention in the doseÊ escalation portion, the sponsor decided to close the trial.

[ "Business_Administrative", "Safety_Sideeffects" ]

false

true

false

true

false

Gm test became routinely available. We could not compare the two arms anymore.

[ "Study_Design" ]

false

true

false

Grant application was not funded

[ "Logistics_Resources" ]

false

true

false

Grant expired

[ "Business_Administrative" ]

false

true

false

Greater differences between randomized patients than previously anticipated

[ "Study_Design", "Negative" ]

false

true

false

true

false

Had been finished

[ "No_Context" ]

false

true

false

Halted by NICHD after recommendation by DSMC to stop for futility

[ "Negative" ]

false

true

false

Halted prematurely due to low enrollment

[ "Insufficient_Enrollment" ]

false

true

false

Halted prematurely due to slow accrual

[ "Insufficient_Enrollment" ]

false

true

false

HandyLab device determined to not work for the science

[ "Logistics_Resources" ]

false

true

false

HandyLab device did not work for the science

[ "Logistics_Resources" ]

false

true

false