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stringlengths
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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
"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