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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
"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 |