opentargets/clinical_trial_reason_to_stop · Datasets at Hugging Face

text stringlengths 4 164	label_descriptions sequence	Another_Study bool 2 classes	Business_Administrative bool 2 classes	Covid19 bool 2 classes	Endpoint_Met bool 2 classes	Ethical_Reason bool 2 classes	Insufficient_Data bool 2 classes	Insufficient_Enrollment bool 2 classes	Interim_Analysis bool 2 classes	Invalid_Reason bool 2 classes	Logistics_Resources bool 2 classes	Negative bool 2 classes	No_Context bool 2 classes	Regulatory bool 2 classes	Safety_Sideeffects bool 2 classes	Study_Design bool 2 classes	Study_Staff_Moved bool 2 classes	Success bool 2 classes
Health Canada Approval date reached, no extension applied for"	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Hepatic Safety Signal Identified.	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
Hepatic safety signal identified.	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
Hiatus for administrative reasons.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
High dose citrulline treatment throughout pregnancy in rats may lead to elevated blood pressure in the offspring.	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
High dropout, problems recruiting, and smaller than expected decline in FEV1."	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
High incidence of TTP, poor recrual	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
High number of screen failures-could not find qualified subjects in timely manner	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Higher drop out than expected. Lower Statistical Power.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Higher hemorrhage rates of Abciximab in ABESST II trial	[ "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Higher incidence of hospitalization for congestive heart failure in pioglitazone-treated subjects compared to glyburide treated subjects.	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Higher incidence of hospitalization for congestive heart failure in pioglitazone-treated Ê subjects compared to glyburide treated subjects.	[ "No_Context" ]	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false
Higher than expected rate of acute rejection	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
Hurricane caused closure of hospital with PI not associated with Shriners Hospital for Ê children	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
I am relocating to Johns Hopkins Medical Center	[ "Study_Staff_Moved" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false
IDE not submitted	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
IDMC recommendation	[ "Regulatory" ]	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false
IMP expired prior to completion of recruitment	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
IMP supply	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
IND application withdrawn	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
IND exemption pending	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
INHERENT MODIFICATIONS NEEDED BEFORE PROCEEDING	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
IRB Closure	[ "Ethical_Reason", "Regulatory" ]	false	false	false	false	true	false	false	false	false	false	false	false	true	false	false	false	false
IRB Study Closure	[ "Business_Administrative", "Regulatory" ]	false	true	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false
IRB approval expired	[ "Regulatory" ]	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false
IRB approval has lapsed.	[ "Regulatory" ]	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false
IRB has requested additional information regarding IDE	[ "Regulatory" ]	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false
IRB is requesting changes to the protocol	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
IRB needs updated	[ "Regulatory" ]	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false
IRB process never completed.	[ "Business_Administrative", "Logistics_Resources" ]	false	true	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
IRB recruitment suspension due to COVID-19 related research restrictions.	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
IRB request	[ "Regulatory" ]	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false
IRB study closure by investigator due to low enrollment	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
ITF2357 (Givinostat) was well tollerated but had limited activity against refractory/relapsed HL	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Identical study Biomed 777-CLP-029 did not meet superiority endpoint	[ "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Illness of PI forced termination.	[ "Study_Staff_Moved" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false
Implantation rate significantly lower in treatment group than Controls.	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Impossibility to accomplish the sample size in assigned time.	[ "Logistics_Resources", "Insufficient_Enrollment", "Study_Design" ]	false	false	false	false	false	false	true	false	false	true	false	false	false	false	true	false	false
In 14 participants who had LP, very low level viremia was found in only 1	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
In 2013 the FDA put a temporary hold on the trial and the Phase II portion of this study wasÊ cancelled.	[ "Regulatory" ]	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false
In a Phase II study in HIV-infected patients there were a number of seizures, although exactÊ causality could not be assessed phase 1 activity was terminated.	[ "Safety_Sideeffects", "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	true	false	false	false
In accordance with protocol's predefined criteria and Data Monitoring Committee recommendation due to insufficient level of efficacy	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
In light of the cessation of non-essential clinical activities at CPU due to the COVID-19	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
In light of the company's current financial position we have indefinately suspended the Rheo-AMD trial.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
In most sites had difficult to recruitting subjects.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
In order to join forces with another study already running which aims to answer the same question.	[ "Another_Study" ]	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
In process of renewing IND for AMP	[ "Regulatory" ]	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false
In response to COVID-19.	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
In the Netherlands we wanted to add pilimumab to nivolumab. This resulted in a very long METCÊ procedure which resulted in a to slow inclusion rate.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
In the intermediate analysis, no effect could be shown, not even a tendency."	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
In the process of transferring IRB to PI's current institution.	[ "Study_Staff_Moved" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false
Inability meet enrollment in study population.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inability to accrue additional sites and enroll an adequate number of subjects.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inability to attain sufficient numbers of subjects	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inability to enroll subjects	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inability to enroll subjects.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inability to obtain grant funding	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Inability to perform the study at present time.	[ "Logistics_Resources" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Inability to reach statistical significance toward primary endpoint	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Inability to recruit	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inability to recruit and adequate number of participants	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inability to recruit eligible subjects	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inability to recruit in time a sufficient number of patients	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inability to recruit required number of subjects.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inability to recruit required sample size.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inability to recruit sufficient number of patients	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inability to reliably measure plasma oxytocin levels during third stage labour, regardless ofÊ administration method (intramuscular or inhaled).	[ "Study_Design" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false
Inadequate Enrollment	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inadequate accrual rate	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inadequate accrural rates	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inadequate eligible subjects to expect sufficient numbers to analyse outcomes.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inadequate enrollement	[ "Logistics_Resources", "Study_Design" ]	false	false	false	false	false	false	false	false	false	true	false	false	false	false	true	false	false
Inadequate enrollment	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inadequate enrollment.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inadequate funding	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Inadequate funding to support this fellow-in-training initiated study.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Inadequate number of eligible patients	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inadequate number of records screened; primary investigator left institution.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inadequate patient recruitment	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inadequate rate of enrollment	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inadequate recruitment	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inadequate recruitment to meet completion date	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inadequate retention of GHD adults to maintain power to study the effect of GH on fibrinolysis. A comparison between GHD adults and controls was completed.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inadequate toxicity	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
Incidence of GI Perforation	[ "Safety_Sideeffects" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false	false	false
Incidence of abnormalities of liver function tests is higher than expected in this population.	[ "Safety_Sideeffects", "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	true	false	false	false
Inclusion rate too low due to a lack of eligible patients and difficulties obtaining informed consent.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inclusion, treatments and follow-up are finished"	[ "Invalid_Reason" ]	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false
Inclusion-rate does not seem feasible anymore to obtain te required number of patients before the end of the trial.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Inclusion/Exclusion criteria was too stringent to enroll patients at this site.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Incomplete data	[ "Insufficient_Data" ]	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false	false
Incorporating the recommendations of the NIH-formed DSMB in the study procedures would make the project budget over the limit for this funding mechanism.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Increased use of commercial product; less eligible patients & poor enrollment.	[ "Insufficient_Enrollment" ]	false	false	false	false	false	false	true	false	false	false	false	false	false	false	false	false	false
Incyte has suspended development of the compound.	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Independent steering committee has stopped the trial based on results of a prespecified, blinded interim analysis. It was not stopped due to safety concerns."	[ "Negative" ]	false	false	false	false	false	false	false	false	false	false	true	false	false	false	false	false	false
Industry Funding Withdrawn	[ "Business_Administrative", "Logistics_Resources" ]	false	true	false	false	false	false	false	false	false	true	false	false	false	false	false	false	false
Industry support and funding not forthcoming	[ "Business_Administrative" ]	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Infectious Disease Outbreak: COVID-19	[ "Covid19" ]	false	false	true	false	false	false	false	false	false	false	false	false	false	false	false	false	false
Initial PI Dr. Marentis left the University of Michigan hospital	[ "Study_Staff_Moved" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false
Initial PI left, study not continued	[ "Study_Staff_Moved" ]	false	false	false	false	false	false	false	false	false	false	false	false	false	false	false	true	false

Health Canada Approval date reached, no extension applied for"

[ "Business_Administrative" ]

false

true

false

Hepatic Safety Signal Identified.

[ "Safety_Sideeffects" ]

false

true

false

Hepatic safety signal identified.

[ "Safety_Sideeffects" ]

false

true

false

Hiatus for administrative reasons.

[ "Business_Administrative" ]

false

true

false

High dose citrulline treatment throughout pregnancy in rats may lead to elevated blood pressure in the offspring.

[ "Safety_Sideeffects" ]

false

true

false

High dropout, problems recruiting, and smaller than expected decline in FEV1."

[ "Negative" ]

false

true

false

High incidence of TTP, poor recrual

[ "Negative" ]

false

true

false

High number of screen failures-could not find qualified subjects in timely manner

[ "Insufficient_Enrollment" ]

false

true

false

Higher drop out than expected. Lower Statistical Power.

[ "Insufficient_Enrollment" ]

false

true

false

Higher hemorrhage rates of Abciximab in ABESST II trial

[ "Another_Study" ]

true

false

Higher incidence of hospitalization for congestive heart failure in pioglitazone-treated subjects compared to glyburide treated subjects.

[ "Negative" ]

false

true

false

Higher incidence of hospitalization for congestive heart failure in pioglitazone-treated Ê subjects compared to glyburide treated subjects.

[ "No_Context" ]

false

true

false

Higher than expected rate of acute rejection

[ "Safety_Sideeffects" ]

false

true

false

Hurricane caused closure of hospital with PI not associated with Shriners Hospital for Ê children

[ "Logistics_Resources" ]

false

true

false

I am relocating to Johns Hopkins Medical Center

[ "Study_Staff_Moved" ]

false

true

false

IDE not submitted

[ "Business_Administrative" ]

false

true

false

IDMC recommendation

[ "Regulatory" ]

false

true

false

IMP expired prior to completion of recruitment

[ "Business_Administrative" ]

false

true

false

IMP supply

[ "Logistics_Resources" ]

false

true

false

IND application withdrawn

[ "Business_Administrative" ]

false

true

false

IND exemption pending

[ "Business_Administrative" ]

false

true

false

INHERENT MODIFICATIONS NEEDED BEFORE PROCEEDING

[ "Study_Design" ]

false

true

false

IRB Closure

[ "Ethical_Reason", "Regulatory" ]

false

true

false

true

false

IRB Study Closure

[ "Business_Administrative", "Regulatory" ]

false

true

false

true

false

IRB approval expired

[ "Regulatory" ]

false

true

false

IRB approval has lapsed.

[ "Regulatory" ]

false

true

false

IRB has requested additional information regarding IDE

[ "Regulatory" ]

false

true

false

IRB is requesting changes to the protocol

[ "Study_Design" ]

false

true

false

IRB needs updated

[ "Regulatory" ]

false

true

false

IRB process never completed.

[ "Business_Administrative", "Logistics_Resources" ]

false

true

false

true

false

IRB recruitment suspension due to COVID-19 related research restrictions.

[ "Covid19" ]

false

true

false

IRB request

[ "Regulatory" ]

false

true

false

IRB study closure by investigator due to low enrollment

[ "Insufficient_Enrollment" ]

false

true

false

ITF2357 (Givinostat) was well tollerated but had limited activity against refractory/relapsed HL

[ "Negative" ]

false

true

false

Identical study Biomed 777-CLP-029 did not meet superiority endpoint

[ "Another_Study" ]

true

false

Illness of PI forced termination.

[ "Study_Staff_Moved" ]

false

true

false

Implantation rate significantly lower in treatment group than Controls.

[ "Negative" ]

false

true

false

Impossibility to accomplish the sample size in assigned time.

[ "Logistics_Resources", "Insufficient_Enrollment", "Study_Design" ]

false

true

false

true

false

true

false

In 14 participants who had LP, very low level viremia was found in only 1

[ "Insufficient_Enrollment" ]

false

true

false

In 2013 the FDA put a temporary hold on the trial and the Phase II portion of this study wasÊ cancelled.

[ "Regulatory" ]

false

true

false

In a Phase II study in HIV-infected patients there were a number of seizures, although exactÊ causality could not be assessed phase 1 activity was terminated.

[ "Safety_Sideeffects", "Negative" ]

false

true

false

true

false

In accordance with protocol's predefined criteria and Data Monitoring Committee recommendation due to insufficient level of efficacy

[ "Negative" ]

false

true

false

In light of the cessation of non-essential clinical activities at CPU due to the COVID-19

[ "Covid19" ]

false

true

false

In light of the company's current financial position we have indefinately suspended the Rheo-AMD trial.

[ "Business_Administrative" ]

false

true

false

In most sites had difficult to recruitting subjects.

[ "Insufficient_Enrollment" ]

false

true

false

In order to join forces with another study already running which aims to answer the same question.

[ "Another_Study" ]

true

false

In process of renewing IND for AMP

[ "Regulatory" ]

false

true

false

In response to COVID-19.

[ "Covid19" ]

false

true

false

In the Netherlands we wanted to add pilimumab to nivolumab. This resulted in a very long METCÊ procedure which resulted in a to slow inclusion rate.

[ "Insufficient_Enrollment" ]

false

true

false

In the intermediate analysis, no effect could be shown, not even a tendency."

[ "Negative" ]

false

true

false

In the process of transferring IRB to PI's current institution.

[ "Study_Staff_Moved" ]

false

true

false

Inability meet enrollment in study population.

[ "Insufficient_Enrollment" ]

false

true

false

Inability to accrue additional sites and enroll an adequate number of subjects.

[ "Insufficient_Enrollment" ]

false

true

false

Inability to attain sufficient numbers of subjects

[ "Insufficient_Enrollment" ]

false

true

false

Inability to enroll subjects

[ "Insufficient_Enrollment" ]

false

true

false

Inability to enroll subjects.

[ "Insufficient_Enrollment" ]

false

true

false

Inability to obtain grant funding

[ "Business_Administrative" ]

false

true

false

Inability to perform the study at present time.

[ "Logistics_Resources" ]

false

true

false

Inability to reach statistical significance toward primary endpoint

[ "Negative" ]

false

true

false

Inability to recruit

[ "Insufficient_Enrollment" ]

false

true

false

Inability to recruit and adequate number of participants

[ "Insufficient_Enrollment" ]

false

true

false

Inability to recruit eligible subjects

[ "Insufficient_Enrollment" ]

false

true

false

Inability to recruit in time a sufficient number of patients

[ "Insufficient_Enrollment" ]

false

true

false

Inability to recruit required number of subjects.

[ "Insufficient_Enrollment" ]

false

true

false

Inability to recruit required sample size.

[ "Insufficient_Enrollment" ]

false

true

false

Inability to recruit sufficient number of patients

[ "Insufficient_Enrollment" ]

false

true

false

Inability to reliably measure plasma oxytocin levels during third stage labour, regardless ofÊ administration method (intramuscular or inhaled).

[ "Study_Design" ]

false

true

false

Inadequate Enrollment

[ "Insufficient_Enrollment" ]

false

true

false

Inadequate accrual rate

[ "Insufficient_Enrollment" ]

false

true

false

Inadequate accrural rates

[ "Insufficient_Enrollment" ]

false

true

false

Inadequate eligible subjects to expect sufficient numbers to analyse outcomes.

[ "Insufficient_Enrollment" ]

false

true

false

Inadequate enrollement

[ "Logistics_Resources", "Study_Design" ]

false

true

false

true

false

Inadequate enrollment

[ "Insufficient_Enrollment" ]

false

true

false

Inadequate enrollment.

[ "Insufficient_Enrollment" ]

false

true

false

Inadequate funding

[ "Business_Administrative" ]

false

true

false

Inadequate funding to support this fellow-in-training initiated study.

[ "Business_Administrative" ]

false

true

false

Inadequate number of eligible patients

[ "Insufficient_Enrollment" ]

false

true

false

Inadequate number of records screened; primary investigator left institution.

[ "Insufficient_Enrollment" ]

false

true

false

Inadequate patient recruitment

[ "Insufficient_Enrollment" ]

false

true

false

Inadequate rate of enrollment

[ "Insufficient_Enrollment" ]

false

true

false

Inadequate recruitment

[ "Insufficient_Enrollment" ]

false

true

false

Inadequate recruitment to meet completion date

[ "Insufficient_Enrollment" ]

false

true

false

Inadequate retention of GHD adults to maintain power to study the effect of GH on fibrinolysis. A comparison between GHD adults and controls was completed.

[ "Insufficient_Enrollment" ]

false

true

false

Inadequate toxicity

[ "Safety_Sideeffects" ]

false

true

false

Incidence of GI Perforation

[ "Safety_Sideeffects" ]

false

true

false

Incidence of abnormalities of liver function tests is higher than expected in this population.

[ "Safety_Sideeffects", "Negative" ]

false

true

false

true

false

Inclusion rate too low due to a lack of eligible patients and difficulties obtaining informed consent.

[ "Insufficient_Enrollment" ]

false

true

false

Inclusion, treatments and follow-up are finished"

[ "Invalid_Reason" ]

false

true

false

Inclusion-rate does not seem feasible anymore to obtain te required number of patients before the end of the trial.

[ "Insufficient_Enrollment" ]

false

true

false

Inclusion/Exclusion criteria was too stringent to enroll patients at this site.

[ "Insufficient_Enrollment" ]

false

true

false

Incomplete data

[ "Insufficient_Data" ]

false

true

false

Incorporating the recommendations of the NIH-formed DSMB in the study procedures would make the project budget over the limit for this funding mechanism.

[ "Business_Administrative" ]

false

true

false

Increased use of commercial product; less eligible patients & poor enrollment.

[ "Insufficient_Enrollment" ]

false

true

false

Incyte has suspended development of the compound.

[ "Business_Administrative" ]

false

true

false

Independent steering committee has stopped the trial based on results of a prespecified, blinded interim analysis. It was not stopped due to safety concerns."

[ "Negative" ]

false

true

false

Industry Funding Withdrawn

[ "Business_Administrative", "Logistics_Resources" ]

false

true

false

true

false

Industry support and funding not forthcoming

[ "Business_Administrative" ]

false

true

false

Infectious Disease Outbreak: COVID-19

[ "Covid19" ]

false

true

false

Initial PI Dr. Marentis left the University of Michigan hospital

[ "Study_Staff_Moved" ]

false

true

false

Initial PI left, study not continued

[ "Study_Staff_Moved" ]

false

true

false