The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
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Number of Patients With Adverse Drug Reactions in This Surveillance
Timeframe: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
The Number of Participants Who Experienced an Adverse Drug Reaction Not Expected From the Local Product Document (Unknown Adverse Drug Reactions)
Timeframe: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
Number of Participants With Adverse Drug Reactions by Gender
Timeframe: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
Number of Participants With Adverse Drug Reactions by Age
Timeframe: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
Number of Participants With Adverse Drug Reactions by Diagnosis
Timeframe: 6.5 years at maximum (therapeutic) and 8.5 years at maximum (preventive)
Clinical Response Rate (Therapeutic)
Timeframe: 6.5 years (at maximum)
Clinical Response Rate (Therapeutic) by Gender
Timeframe: 6.5 years (at maximum)
Clinical Response Rate (Therapeutic) by Age
Timeframe: 6.5 years (at maximum)
Clinical Response Rate (Therapeutic) by Diagnosis
Timeframe: 6.5 years (at maximum)