opentargets/clinical_trial_reason_to_stop · Datasets at Hugging Face

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
"Tapering doses" protocol arm was not effective for treatment retention outcome.	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
1 Indication for further investigations (brain ultrasound). 2 Change of study design toÊ efficacy study with historical control group.	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
1. Very low enrollment rate. Ê Ê 2. Recent studies question the effect of adding panitumumab in this category of patients. Ê Ê 3. Too high toxicity rate	[ "Insufficient_Enrollment", "Safety_Sideeffects", "Another_Study" ]	true	false	false	false	false	false	true	false	false	false	false	false	false	true	false	false	false
10/2005 PI assigned duties as trauma physician in addition other duties	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
12/15/2008 Voluntarily placed on inactive status-requested by the PI	[ "Invalid_Reason" ]	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false
13 of 15 patients recruited.Study patients responded with no safety signals. RecruitmentÊ slow,timely end of study necessary to keep development timelines	[ "Business_Administrative", "Insufficient_Enrollment" ]	false	true	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
2 complications with midazolam	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
20 subjects completed for a pilot, further funding required to continue study"	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
2011 Thailand flooding led to loss of GMP pharmacy, project delays, and further regulatory Ê challenges.	[ "Logistics_Resources", "Regulatory" ]	false	false	false	false	false	false	false	false	false	true	false	false	true	false	false	false	false
36 cases were included and the 4 centers and they are unable to increase their recruitment to obtain the 400 cases necessary to reach statistical significance.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
5 immune related serious adverse events in Phase 1 study	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
50% of eligible patients refused to enter the study	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
6 month vital status report not collected after 28 day follow up analysis indicated no difference between placebo & tezosentan	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
65 patients were included after 2 years instead of 140	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
7% enrollment. Study terminated after a small number of recruited patients	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
A 300 patient safety analysis by the Data Monitoring Committee showed a trend towards higher mortality in the treatment group.	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
A business decision was made to not initiate this study.	[ "Business_Administrative", "Invalid_Reason" ]	false	true	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false
A cluster of adverse events in everolimus arm was noted.	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
A cluster of deaths in the BCG-arm compared with controls	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
A decision was made to discontinue the study due to a change in the strategic direction of the company.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
A decision was made to not move forward with the study. No participants were enrolled or Ê treated.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
A higher rate of late rejection was seen in the low tacrolimus arm.	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
A lack of a potential patient.	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
A new alternative treatment caused the decrease in the rhythm of recruitment.	[ "Insufficient_Enrollment", "Another_Study" ]	true	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
A new alternative treatment for patients who have progressed after treatment with trastuzumab, has caused the decrease in the rhythm of recruitment."	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
A new protocol was developed to replace this protocol in 2008, with removal of ATG andÊ extension of MMF duration.	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
A new study has began recently	[ "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
A new study is being designed. No patients were enrolled.	[ "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
A paper on the same topic came out just before we wanted to start our study.	[ "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
A pending new protocol will replace this study.	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
A planned interim analysis was performed after approx. 240 subjects completed the trial. The study was stopped, as permitted by protocol, after the analysis."	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
A preliminary analysis of 11 patients confirmed the safety profile of NCX-1000 but did not demonstrate the efficacy required.	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
A re-evaluation of research risks to participants were greater than originally anticipated	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
A significant reduction in head injuries coupled with more frequent use of crainectomy reduced Ê the number of potential subjects.	[ "Insufficient_Enrollment", "Study_Design" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	true	false	false
A sister study using Frova at a 10 mg dose had adverse effects.	[ "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
AG-1749 superior to Gefarnate in ulcer prevention	[ "Success", "Endpoint_Met", "Negative" ]	false	false	false	true	false	false	false	false	false	false	true	false	false	false	false	false	true
AMAG not continuing with Combidex, the study drug"	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
AML assessment of response in the Part B patients (9) find treatment failure in all instances.	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
AOI Pharma is reassessing the development strategy for perifosine.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
AOI Pharmaceuticals, Inc. decided to terminate the license agreement. No further clinical development by AOI Pharmaceuticals, Inc. will be pursued."	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
APPRISE closure prompted by SWOG S0205 not meeting primary endpoint-improving OS. APPRISE enrollment closure due to similar design;no unexpected safety data	[ "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
AVE5530 in hypercholesterolemia was stopped due to insufficient efficacy	[ "Study_Design", "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	true	false	false
AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Ê Rigel Pharmaceuticals.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
AZD1704 has essentially similar PK profile in Japanese subjects as in Caucasians. One of the main purposes of the study has thereby been achieved.	[ "Endpoint_Met" ]	false	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false
Abandoned due to lack of recruitment Oct 2006	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Abnormality prevalence revealed to be much lower than expected.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Absence of patients for recruitment	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
According to the study design, in the first step the number of responses was lower than the number required (< 7)."	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Accrual Goal Met	[ "Invalid_Reason" ]	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false
Accrual and treatment with CG1940/CG8711 stopped due to IDMC recommendation.	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Accrual factor	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Accrual goal for interventional part not achievable	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Accrual has been very slow. We are currently determining whether or not to keep the trial going as is or to close the trial and write a new protocol.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Accrual is suspended due to COVID-19.	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Accrual is very poor	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Accrual problems	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Accrual rate was too low	[ "Insufficient_Enrollment", "Study_Design" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	true	false	false
Accrual too difficult to meet	[ "Logistics_Resources", "Study_Design" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	true	false	false
Accrual was not optimized	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Accrual was suboptimal and increasing the number of patients was not feasible.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Accrural was completed	[ "Invalid_Reason" ]	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false
Achieving site readiness and enrolling the trial within a reasonable time	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Acrrual target was not being met	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Active Duty principle investigator currently deployed	[ "Business_Administrative", "Study_Staff_Moved" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false
Additional equipment is needed.	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Additional research	[ "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Administrative	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Administrative closed due to funding	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Administrative reasons	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Administrative reasons.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Administrative suspension	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Administratively complete.	[ "Business_Administrative", "Endpoint_Met", "Invalid_Reason", "Success" ]	false	true	false	true	false	false	false	false	true	false	false	false	false	false	false	false	true
Adult patient population barriers.	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Adverse Events	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Adverse findings from nonclinical carcinogenicity studies.	[ "Safety_Sideeffects", "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
After 1 year only 2 subjects enrolled and treated thus no meaningful efficacy analyses could be performed.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
After 190 weeks [7 patients left] it was terminated for administrative reasons	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
After IELSG25A study amendment, patients subject of the present study were eligible for inclusion in the IELSG25A study"	[ "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
After Preliminary results indicate need to make numerous changes to protocol, and therfore will end, rewrite, and then begin again."	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
After a discussion, we decided to withdraw the study."	[ "Invalid_Reason" ]	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false
After an extensive review,the ASPIRE in CKD study was terminated because it was not possible to complete the study in an appropriate time frame."	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
After an extensive review,the ASPIRE in CKD study was terminated because it was not possibleÊ to complete the study in an appropriate time frame.	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
After initiation of study many studies reported an equivalence of SNB and ALND which led to Ê widespread adoption of the former as standard procedure.	[ "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
After interim analysis it was determined that the risks were too great in comparision to theÊ results	[ "Safety_Sideeffects", "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	true	false	false	false
After interims analysis standard errors for inflammatory and nutritional markers varied Ê widely, that the power calculation required unattainable goals	[ "Study_Design", "Insufficient_Data" ]	false	false	false	false	false	true	false	false	false	false	false	false	false	false	true	false	false
After pilot study no difference in the primary end point was found between the two primary.Ê Non-inferiority trial not deemed feasible.	[ "Logistics_Resources", "Study_Design", "Negative" ]	false	false	false	false	false	false	false	false	false	true	true	false	false	false	true	false	false
After primary completition date, experimental drug was no longer available	[ "Logistics_Resources", "Study_Design", "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	true	false	false	false	false	true	false	false
After reports of turbidity in urine in 4 of 8 volunteers in the 4th cohort, the study was halted temporarily."	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
After review of safety events and have decided that further dose escalation of MEDI-507 as a single agent is not feasible.	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
After treatment of 7 patients, it was decided that the handling characteristics of the test device should be upgraded before continuing the trial as planned."	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
After utilizing all available recruitment resources, it was determined that the recruitment goal for the study could not be achieved"	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
After year 1, there was insufficient statistical power to detect a difference in the primary outcome measure during planned study period."	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Aims of the study re-evaluated, did not justify allocation of resources."	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
All AstraZeneca sponsored clinical trials of AZD8931 have been halted	[ "No_Context" ]	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false
All enrollment, treatment, follow-up & data analysis completed"	[ "Invalid_Reason" ]	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false
All of the mentioned aim and objectives were achieved before the February 2007	[ "Endpoint_Met" ]	false	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false
All patients during the study period were subjected to peripheral blocks or were excluded fromÊ the study due to exclusion criteria	[ "Endpoint_Met", "Safety_Sideeffects" ]	false	false	false	true	false	false	false	false	false	false	false	false	false	true	false	false	false
All patients recruited	[ "Invalid_Reason" ]	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false
All sites have been put on hold due to the ongoing COVID-19 pandemic	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
All subject enrollment/follow up is on hold due to COVID-19 pandemic	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false

"Tapering doses" protocol arm was not effective for treatment retention outcome.

[ "Negative" ]

false

true

false

1 Indication for further investigations (brain ultrasound). 2 Change of study design toÊ efficacy study with historical control group.

[ "Study_Design" ]

false

true

false

1. Very low enrollment rate. Ê Ê 2. Recent studies question the effect of adding panitumumab in this category of patients. Ê Ê 3. Too high toxicity rate

[ "Insufficient_Enrollment", "Safety_Sideeffects", "Another_Study" ]

true

false

true

false

true

false

10/2005 PI assigned duties as trauma physician in addition other duties

[ "Business_Administrative" ]

false

true

false

12/15/2008 Voluntarily placed on inactive status-requested by the PI

[ "Invalid_Reason" ]

false

true

false

13 of 15 patients recruited.Study patients responded with no safety signals. RecruitmentÊ slow,timely end of study necessary to keep development timelines

[ "Business_Administrative", "Insufficient_Enrollment" ]

false

true

false

true

false

2 complications with midazolam

[ "Safety_Sideeffects" ]

false

true

false

20 subjects completed for a pilot, further funding required to continue study"

[ "Business_Administrative" ]

false

true

false

2011 Thailand flooding led to loss of GMP pharmacy, project delays, and further regulatory Ê challenges.

[ "Logistics_Resources", "Regulatory" ]

false

true

false

true

false

36 cases were included and the 4 centers and they are unable to increase their recruitment to obtain the 400 cases necessary to reach statistical significance.

[ "Insufficient_Enrollment" ]

false

true

false

5 immune related serious adverse events in Phase 1 study

[ "Safety_Sideeffects" ]

false

true

false

50% of eligible patients refused to enter the study

[ "Insufficient_Enrollment" ]

false

true

false

6 month vital status report not collected after 28 day follow up analysis indicated no difference between placebo & tezosentan

[ "Negative" ]

false

true

false

65 patients were included after 2 years instead of 140

[ "Insufficient_Enrollment" ]

false

true

false

7% enrollment. Study terminated after a small number of recruited patients

[ "Insufficient_Enrollment" ]

false

true

false

A 300 patient safety analysis by the Data Monitoring Committee showed a trend towards higher mortality in the treatment group.

[ "Safety_Sideeffects" ]

false

true

false

A business decision was made to not initiate this study.

[ "Business_Administrative", "Invalid_Reason" ]

false

true

false

true

false

A cluster of adverse events in everolimus arm was noted.

[ "Safety_Sideeffects" ]

false

true

false

A cluster of deaths in the BCG-arm compared with controls

[ "Safety_Sideeffects" ]

false

true

false

A decision was made to discontinue the study due to a change in the strategic direction of the company.

[ "Business_Administrative" ]

false

true

false

A decision was made to not move forward with the study. No participants were enrolled or Ê treated.

[ "Business_Administrative" ]

false

true

false

A higher rate of late rejection was seen in the low tacrolimus arm.

[ "Negative" ]

false

true

false

A lack of a potential patient.

[ "Study_Design" ]

false

true

false

A new alternative treatment caused the decrease in the rhythm of recruitment.

[ "Insufficient_Enrollment", "Another_Study" ]

true

false

true

false

A new alternative treatment for patients who have progressed after treatment with trastuzumab, has caused the decrease in the rhythm of recruitment."

[ "Study_Design" ]

false

true

false

A new protocol was developed to replace this protocol in 2008, with removal of ATG andÊ extension of MMF duration.

[ "Study_Design" ]

false

true

false

A new study has began recently

[ "Another_Study" ]

true

false

A new study is being designed. No patients were enrolled.

[ "Another_Study" ]

true

false

A paper on the same topic came out just before we wanted to start our study.

[ "Another_Study" ]

true

false

A pending new protocol will replace this study.

[ "Study_Design" ]

false

true

false

A planned interim analysis was performed after approx. 240 subjects completed the trial. The study was stopped, as permitted by protocol, after the analysis."

[ "Negative" ]

false

true

false

A preliminary analysis of 11 patients confirmed the safety profile of NCX-1000 but did not demonstrate the efficacy required.

[ "Negative" ]

false

true

false

A re-evaluation of research risks to participants were greater than originally anticipated

[ "Safety_Sideeffects" ]

false

true

false

A significant reduction in head injuries coupled with more frequent use of crainectomy reduced Ê the number of potential subjects.

[ "Insufficient_Enrollment", "Study_Design" ]

false

true

false

true

false

A sister study using Frova at a 10 mg dose had adverse effects.

[ "Another_Study" ]

true

false

AG-1749 superior to Gefarnate in ulcer prevention

[ "Success", "Endpoint_Met", "Negative" ]

false

true

false

true

false

true

AMAG not continuing with Combidex, the study drug"

[ "Business_Administrative" ]

false

true

false

AML assessment of response in the Part B patients (9) find treatment failure in all instances.

[ "Negative" ]

false

true

false

AOI Pharma is reassessing the development strategy for perifosine.

[ "Business_Administrative" ]

false

true

false

AOI Pharmaceuticals, Inc. decided to terminate the license agreement. No further clinical development by AOI Pharmaceuticals, Inc. will be pursued."

[ "Business_Administrative" ]

false

true

false

APPRISE closure prompted by SWOG S0205 not meeting primary endpoint-improving OS. APPRISE enrollment closure due to similar design;no unexpected safety data

[ "Another_Study" ]

true

false

AVE5530 in hypercholesterolemia was stopped due to insufficient efficacy

[ "Study_Design", "Negative" ]

false

true

false

true

false

AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Ê Rigel Pharmaceuticals.

[ "Business_Administrative" ]

false

true

false

AZD1704 has essentially similar PK profile in Japanese subjects as in Caucasians. One of the main purposes of the study has thereby been achieved.

[ "Endpoint_Met" ]

false

true

false

Abandoned due to lack of recruitment Oct 2006

[ "Insufficient_Enrollment" ]

false

true

false

Abnormality prevalence revealed to be much lower than expected.

[ "Insufficient_Enrollment" ]

false

true

false

Absence of patients for recruitment

[ "Insufficient_Enrollment" ]

false

true

false

According to the study design, in the first step the number of responses was lower than the number required (< 7)."

[ "Insufficient_Enrollment" ]

false

true

false

Accrual Goal Met

[ "Invalid_Reason" ]

false

true

false

Accrual and treatment with CG1940/CG8711 stopped due to IDMC recommendation.

[ "Negative" ]

false

true

false

Accrual factor

[ "Insufficient_Enrollment" ]

false

true

false

Accrual goal for interventional part not achievable

[ "Insufficient_Enrollment" ]

false

true

false

Accrual has been very slow. We are currently determining whether or not to keep the trial going as is or to close the trial and write a new protocol.

[ "Insufficient_Enrollment" ]

false

true

false

Accrual is suspended due to COVID-19.

[ "Covid19" ]

false

true

false

Accrual is very poor

[ "Insufficient_Enrollment" ]

false

true

false

Accrual problems

[ "Insufficient_Enrollment" ]

false

true

false

Accrual rate was too low

[ "Insufficient_Enrollment", "Study_Design" ]

false

true

false

true

false

Accrual too difficult to meet

[ "Logistics_Resources", "Study_Design" ]

false

true

false

true

false

Accrual was not optimized

[ "Insufficient_Enrollment" ]

false

true

false

Accrual was suboptimal and increasing the number of patients was not feasible.

[ "Insufficient_Enrollment" ]

false

true

false

Accrural was completed

[ "Invalid_Reason" ]

false

true

false

Achieving site readiness and enrolling the trial within a reasonable time

[ "Insufficient_Enrollment" ]

false

true

false

Acrrual target was not being met

[ "Insufficient_Enrollment" ]

false

true

false

Active Duty principle investigator currently deployed

[ "Business_Administrative", "Study_Staff_Moved" ]

false

true

false

true

false

Additional equipment is needed.

[ "Logistics_Resources" ]

false

true

false

Additional research

[ "Another_Study" ]

true

false

Administrative

[ "Business_Administrative" ]

false

true

false

Administrative closed due to funding

[ "Business_Administrative" ]

false

true

false

Administrative reasons

[ "Business_Administrative" ]

false

true

false

Administrative reasons.

[ "Business_Administrative" ]

false

true

false

Administrative suspension

[ "Business_Administrative" ]

false

true

false

Administratively complete.

[ "Business_Administrative", "Endpoint_Met", "Invalid_Reason", "Success" ]

false

true

false

true

false

true

false

true

Adult patient population barriers.

[ "Study_Design" ]

false

true

false

Adverse Events

[ "Negative" ]

false

true

false

Adverse findings from nonclinical carcinogenicity studies.

[ "Safety_Sideeffects", "Another_Study" ]

true

false

true

false

After 1 year only 2 subjects enrolled and treated thus no meaningful efficacy analyses could be performed.

[ "Insufficient_Enrollment" ]

false

true

false

After 190 weeks [7 patients left] it was terminated for administrative reasons

[ "Business_Administrative" ]

false

true

false

After IELSG25A study amendment, patients subject of the present study were eligible for inclusion in the IELSG25A study"

[ "Another_Study" ]

true

false

After Preliminary results indicate need to make numerous changes to protocol, and therfore will end, rewrite, and then begin again."

[ "Study_Design" ]

false

true

false

After a discussion, we decided to withdraw the study."

[ "Invalid_Reason" ]

false

true

false

After an extensive review,the ASPIRE in CKD study was terminated because it was not possible to complete the study in an appropriate time frame."

[ "Logistics_Resources" ]

false

true

false

After an extensive review,the ASPIRE in CKD study was terminated because it was not possibleÊ to complete the study in an appropriate time frame.

[ "Logistics_Resources" ]

false

true

false

After initiation of study many studies reported an equivalence of SNB and ALND which led to Ê widespread adoption of the former as standard procedure.

[ "Another_Study" ]

true

false

After interim analysis it was determined that the risks were too great in comparision to theÊ results

[ "Safety_Sideeffects", "Negative" ]

false

true

false

true

false

After interims analysis standard errors for inflammatory and nutritional markers varied Ê widely, that the power calculation required unattainable goals

[ "Study_Design", "Insufficient_Data" ]

false

true

false

true

false

After pilot study no difference in the primary end point was found between the two primary.Ê Non-inferiority trial not deemed feasible.

[ "Logistics_Resources", "Study_Design", "Negative" ]

false

true

false

true

false

After primary completition date, experimental drug was no longer available

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

false

true

false

true

false

true

false

After reports of turbidity in urine in 4 of 8 volunteers in the 4th cohort, the study was halted temporarily."

[ "Safety_Sideeffects" ]

false

true

false

After review of safety events and have decided that further dose escalation of MEDI-507 as a single agent is not feasible.

[ "Safety_Sideeffects" ]

false

true

false

After treatment of 7 patients, it was decided that the handling characteristics of the test device should be upgraded before continuing the trial as planned."

[ "Logistics_Resources" ]

false

true

false

After utilizing all available recruitment resources, it was determined that the recruitment goal for the study could not be achieved"

[ "Insufficient_Enrollment" ]

false

true

false

After year 1, there was insufficient statistical power to detect a difference in the primary outcome measure during planned study period."

[ "Negative" ]

false

true

false

Aims of the study re-evaluated, did not justify allocation of resources."

[ "Business_Administrative" ]

false

true

false

All AstraZeneca sponsored clinical trials of AZD8931 have been halted

[ "No_Context" ]

false

true

false

All enrollment, treatment, follow-up & data analysis completed"

[ "Invalid_Reason" ]

false

true

false

All of the mentioned aim and objectives were achieved before the February 2007

[ "Endpoint_Met" ]

false

true

false

All patients during the study period were subjected to peripheral blocks or were excluded fromÊ the study due to exclusion criteria

[ "Endpoint_Met", "Safety_Sideeffects" ]

false

true

false

true

false

All patients recruited

[ "Invalid_Reason" ]

false

true

false

All sites have been put on hold due to the ongoing COVID-19 pandemic

[ "Covid19" ]

false

true

false

All subject enrollment/follow up is on hold due to COVID-19 pandemic

[ "Covid19" ]

false

true

false