Glossary entry (derived from question below)
English term or phrase:
safety-evaluable patients
English answer:
those patients meeting the conditions pre-specified by the investigators to assess treatment safety
Added to glossary by
Elena Sgarbo (X)
Jun 21, 2004 16:20
19 yrs ago
12 viewers *
English term
safety-evaluable patients
English
Medical
Medical (general)
clinical trial
Safety Assessments
Treatment-emergent adverse events, clinical laboratory and electrocardiogram data, and vital signs will be summarized by treatment groups for ***safety-evaluable*** patients only.
What do they mean by this?
TIA / Lisa
Treatment-emergent adverse events, clinical laboratory and electrocardiogram data, and vital signs will be summarized by treatment groups for ***safety-evaluable*** patients only.
What do they mean by this?
TIA / Lisa
Responses
Responses
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2 hrs
Selected
those patients meeting the conditions pre-specified by the investigators to assess treatment safety
Hi Lisa
As you know, evaluating safety is an early step in therapy clinical trials. Safety must be evaluated before efficacy can be assessed.
For each trial and each treatment strategy, invstigators must pre-specify what conditions must be met by patients enrolled in their study in order to have the safety of the treatment evaluated.
Those conditions may include receiving a minimum number of doses of the drug, having spent a minimum period as a study patient, and others.
HTH :-)
Elena
As you know, evaluating safety is an early step in therapy clinical trials. Safety must be evaluated before efficacy can be assessed.
For each trial and each treatment strategy, invstigators must pre-specify what conditions must be met by patients enrolled in their study in order to have the safety of the treatment evaluated.
Those conditions may include receiving a minimum number of doses of the drug, having spent a minimum period as a study patient, and others.
HTH :-)
Elena
4 KudoZ points awarded for this answer.
Comment: "Thank you, Elena! "
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all enrolled subjects who received at least one dose of the study drug/treatment
;o)
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patients fulfilling medical requirements to
Patients whose lab tests results are within normal range, therefore they can take the study drug with a minimum o no risk for their health
1 hr
patients with acceptable test results
Before starting an experiment, patients are generally tested for various criteria, to provide a starting point for comparison.
These results must fall within a certain range for the readings to be included in the study, as results outside the normal or average range may indicate a pre-existing condition affecting the performance of the product being tested.
These results must fall within a certain range for the readings to be included in the study, as results outside the normal or average range may indicate a pre-existing condition affecting the performance of the product being tested.
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