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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
All the patients were included | [
"Invalid_Reason"
] | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false |
Alternate study projected to assess imaging endpoints versus clinical endpoints. | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Alternative trial planned | [
"Study_Design"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false |
Amendment requested for this study - waiting for Regulatory Approval of the Amendment | [
"Study_Design"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false |
Amgen decision following interim review of efficacy and safety data from the AMG 337 program. | [
"Interim_Analysis"
] | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false |
Amgen determined no further need for this study. | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
An alternative joint industry effort will provide information on combination versus singleÊ agent therapy for treatment of aspergillosis | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
An endpoint difference between 3 energies was not observed. Correlations between recovery and ATP were established, and will be used for a Whole Blood system." | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
An independent DMC determined continuation was unlikely to demonstrate a statistically significant advantage of ASP8825 over placebo on the primary endpoint | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
An interim analysis revealed a significantly higher persistence/recurrence of complications of portal hypertension in the 8 mm-stent group. | [
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
An interim analysis showed that nitric oxide patches are not enough effective | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
An interim data analysis found no significant difference between testing groups. | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Analysis of data from 104RA202 failed to meet primary endpoint | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Analysis of data from 104RA203 failed to meet primary endpoint. | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Ancillary data being reviewed to determine if this study will continue. | [
"Interim_Analysis"
] | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false |
Angioscanners in excess of the SNA group because of use of thiopental | [
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
Animal Safety Data | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Animal Toxicity Findings | [
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
Another study enrolling the similar group of patient are ongoing | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Another study has been planned, so we did not initiate this one. | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Another study was opened. | [
"Business_Administrative",
"Another_Study"
] | true | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Another treatment found efficacious | [
"Business_Administrative",
"Another_Study"
] | true | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Another trial in the department directly competes for the the same patient population | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Anticipated number of patients not achieved. All Patients recruited in the study completed all study visits. | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Anticipation of inadequate recruitment according to current format. | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Approval lapse | [
"Regulatory"
] | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false |
Arm A - reached goal; Arm B - poor accrual | [
"Insufficient_Enrollment",
"Endpoint_Met"
] | false | false | false | true | false | false | true | false | false | false | false | false | false | false | false | false | false |
As Continuing Review application to IRB was not submitted on time | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
As another Mps1 inhibitor was being developed in parallel, the strategic decision was to moveÊ forward with the development of the follow up compound only. | [
"Business_Administrative",
"Logistics_Resources"
] | false | true | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
As no safety warnings were detected,Interim analysis from the first 40 patients reccomends to stop the trial for futility" | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
As recommended by the DSMB. | [
"Regulatory"
] | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false |
As the recruitment rate was very low, a futility study was conducted and it was decided toÊ discontinue inclusions | [
"Insufficient_Enrollment",
"Negative"
] | false | false | false | false | false | false | true | false | false | false | true | false | false | false | false | false | false |
Assessing resources needed to extend study. | [
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
AstraZeneca has discontinued the development of AZD0530. No new AstraZeneca-sponsored clinical studies will be initiated.. | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
AstraZeneca withdrew support for the study. | [
"Business_Administrative",
"Logistics_Resources"
] | false | true | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
At half the sample size, the results were negative with no benefit demonstrated with Ê adenosine. | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
At interim analysis the study did not meet the response criteria to continue | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
At sponsor's discretion | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
At the end of the year 2002, Cameroon switched from chloroquine to amodiaquine as first-line therapy for of uncomplicated malaria." | [
"Study_Design"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false |
At the first prespecified interim analysis | [
"Interim_Analysis"
] | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false |
Attendance at study sites carries risk of COVID-19 infection. Non-attendance at planned study | [
"Covid19"
] | false | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Authorization denied | [
"Invalid_Reason"
] | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false |
Autorities vorbidden this dispositif in other trial | [
"Study_Design",
"Safety_Sideeffects",
"Regulatory"
] | false | false | false | false | false | false | false | false | false | false | false | false | true | true | true | false | false |
Availability of Investigational agent | [
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
Avastin approved for first-in-line treatment. | [
"Study_Design"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false |
Awaiting IMP license for new GMP suite. | [
"Regulatory"
] | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false |
Azidus, the CRO hired for this study by Prevent Senior has lost the interest to conduct thisÊ study. | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
B2151007 was prematurely discontinued due to Pfizer's change in prioritization for theÊ portfolio and is not due to any safety concerns or regulatory interaction | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
BMS withdrew support and required this trial to stop enrolling; Phase II portion never began,Ê only a Phase I trial. | [
"Regulatory"
] | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false |
Based on Independent Data Monitoring Committee (IDMC) recommendation. | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Based on a business decision unrelated to any safety concerns. | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Based on a consistently low enrolment rate and procedural challenges that were unknown at study start. It was not based on safety or efficacy concerns. | [
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
Based on an interim data review, the DSMB concluded that the vaccine cannot be shown in this trial to prevent HIV infection or affect the course of the disease." | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Based on analyses in Phase I, the study did not advance to Phase II. | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Based on analysis of results and consideration of available treatments, the overall benefit toÊ risk profile of ocrelizumab was not favorable in RA. | [
"Business_Administrative",
"Negative"
] | false | true | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Based on data collected, the combination appeared to be poorly tolearated." | [
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
Based on futility analysis showing <30% chance of meeting primary endpoint. | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Based on input from regulatory agencies, it is not necessary to conduct this study. An ongoing study was sufficient for regulatory purposes." | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Based on interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment was stopped due to lack of efficacy" | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Based on interim analysis at the end of Stage 1, and predefined stopping rules for futility,Ê further enrollment was stopped due to lack of efficacy | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Based on overall benefit-risk assessment. | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Based on preliminary parent study results | [
"No_Context",
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false |
Based on the data and observed benefit-risk profile, the trial's independent oversight committee recommended that enrollment not resume." | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Based on the data collected, the combination of bevacizumab and sunitinib appeared to be poorly tolerated." | [
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
Based on the outcome of the planned first interim analysis, it was decided not to continue the trial. No safety concerns were identified." | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Based on the results of the Phase 1 data, the company decided not to pursue the development ofÊ this drug at this time. | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Based upon preliminary safety and efficacy results from a similar study. | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Bayer Healthcare is no supplying the study drug | [
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
Bayer terminated the program and sold the IP to Medronic | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Beacuse of unexpected administrative barriers, only 5 cases were enrolled in a year." | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Because of a strategic decision by Novartis | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Because of approval of Bevacizumab, it was difficult to perform clinical study in 1st line setting." | [
"Study_Design"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false |
Because of lack of funding and recruitment problems the study has been closed. | [
"Logistics_Resources",
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | true | false | false | false | false | false | false | false |
Because of many competing trials using the same mechanism of action, but being further advancedÊ in development | [
"Business_Administrative",
"Study_Design"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false |
Because of negative results of the sister study NAK-06 and the low overall response rate atÊ week 24. | [
"Another_Study",
"Negative"
] | true | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Because of reconsideration of using erlotinib(EGFR Tyrosine kinase inhibitor) as adjuvant aim | [
"Study_Design"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false |
Because of slow recruitment; Despite the study was started long time ago (Oct 2004), we have not reached the projected number of patients (150 patients)" | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Because of the economic consequences of the COVID-19 pandemic 2020 | [
"Covid19"
] | false | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Because of the epidemic of COVID-19, the serum testing could not be continued | [
"Covid19"
] | false | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Because of the low probability of achieving the primary endpoint. | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Because of unexpectedly reduced disease prevalence in the study area, a pragmatic decision was taken to terminate recruitment in March 2003." | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Because of unsatisfactory results of previous trial which assessed the effect of different onset times of PDL on surgical scars. | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Because of very slow rate of enrollement | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Because of withdrawal of Avandia sale due to its risks outweigh its benefits | [
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
Because only a few patients follow the inclusion and exclusion criteria. | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Because there was no longer an active laboratory component to this study. | [
"Logistics_Resources",
"Study_Staff_Moved"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | true | false |
Because we did not find funds to do it | [
"Business_Administrative",
"Invalid_Reason"
] | false | true | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false |
Big difficulties to enroll patients | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Boston Scientific has decided to close the Study. | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Both sponsor and UCSF decided this study was not clinical relevant at this time | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Budget issues | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Budgetary | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Budgetary restrictions | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Bupivacaine has recently been shown to inhibit osteoclast formation in vitro. | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Business Decision | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Business Decision; No Safety Concerns | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Business Decision; No Safety Or Efficacy Concerns. | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Business Objectives Changed | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Business Objectives Have Changed | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Business Reasons | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |