C20409
Adverse event attribution indicator
Indicator of whether the adverse event was cause by the treatment in question
Supplemental
Serious Adverse Events
False
General (For all diseases)
General (For all diseases)
C02310
Adverse event CTCAE low level term name
Text that represents the Common Terminology Criteria for Adverse Events (CTCAE) low level term name for an adverse event
Supplemental
Serious Adverse Events
False
General (For all diseases)
General (For all diseases)
C02310
Adverse event CTCAE low level term name
Text that represents the Common Terminology Criteria for Adverse Events (CTCAE) low level term name for an adverse event
Supplemental
Adverse Events
False
General (For all diseases)
General (For all diseases)
C02308
Adverse event during study indicator
Indicator of whether the participant/subject experienced any adverse events during the study
Supplemental
Adverse Events
False
General (For all diseases)
General (For all diseases)
C02301
Adverse event end date and time
Date (and time, if applicable and known) on which the adverse event discontinued/stopped
Supplemental
Adverse Events
False
General (For all diseases)
General (For all diseases)
C02311
Adverse event MedDRA lower level term code
Code that corresponds to the Medical Dictionary for Regulatory Activities (MedDRA) Lower Level Term (LLT) for an adverse event
Supplemental
Serious Adverse Events
False
General (For all diseases)
General (For all diseases)
C02311
Adverse event MedDRA lower level term code
Code that corresponds to the Medical Dictionary for Regulatory Activities (MedDRA) Lower Level Term (LLT) for an adverse event
Supplemental
Adverse Events
False
General (For all diseases)
General (For all diseases)
C02302
Adverse event other action taken type
Type of action taken due to adverse event other than action taken with study intervention/ treatment
Supplemental
Adverse Events
False
General (For all diseases)
General (For all diseases)
C02303
Adverse event outcome status
Final status of the participant/subject related to the adverse event
Supplemental
Adverse Events
False
General (For all diseases)
General (For all diseases)
C02304
Adverse event relatedness scale
Scale of the causality between the treatment modality/intervention and the specific adverse event
Supplemental
Adverse Events
False
General (For all diseases)
General (For all diseases)
C20407
Adverse event reporting identifier name
A name of an authorized group or person reporting the adverse event
Supplemental
Serious Adverse Events
False
General (For all diseases)
General (For all diseases)
C02305
Adverse event severity scale grade
The grading scale of the severity or intensity of the adverse event
Supplemental
Adverse Events
False
General (For all diseases)
General (For all diseases)
C02306
Adverse event start date and time
Date (and time, if applicable and known) on which the adverse event was first evident
Supplemental
Adverse Events
False
General (For all diseases)
General (For all diseases)
C02300
Adverse event study intervention action taken type
Type of action taken for adverse event in relation to study intervention
Supplemental
Adverse Events
False
General (For all diseases)
General (For all diseases)
C02307
Adverse event verbatim term text
Text that describes the adverse event word for word as described by the participant/subject
Supplemental
Adverse Events
False
General (For all diseases)
General (For all diseases)
C02307
Adverse event verbatim term text
Text that describes the adverse event word for word as described by the participant/subject
Supplemental
Serious Adverse Events
False
General (For all diseases)
General (For all diseases)
C00008
Age value
Value for participant/subject's age, calculated as elapsed time since the birth of the participant/subject
Supplemental
Serious Adverse Events
False
General (For all diseases)
General (For all diseases)
C00707
Alcohol consume six or more drinks frequency
The rate of occurrence for when the participant/subject consumes six or more drinks containing alcohol on one occasion. It is noted that the meaning of "drinks consumed" differs from one nation and culture to another, so the most common alcoholic beverages likely to be consumed will be defined as well as quantity of each that constitutes a drink (approximately 10 grams of pure ethanol). For example, one bottle of beer (330 ml at 5% ethanol), a glass of wine (140 ml at 12% ethanol), and a shot of spirits (40 ml at 40% ethanol) represent a standard drink of about 13 g of ethanol
Supplemental
Behavioral History
False
General (For all diseases)
General (For all diseases)
C00705
Alcohol current use indicator
Indicator of whether the participant/subject consumed at least one alcoholic drink within the past 12 months
Supplemental
Behavioral History
False
General (For all diseases)
General (For all diseases)
C00704
Alcohol drinking day average drinks consumed range
The counted number of drinks containing alcohol consumed by the participant/subject on a typical day when he/she is drinking. It is noted that the meaning of "drinks consumed" differs from one nation and culture to another, so the most common alcoholic beverages likely to be consumed will be defined as well as quantity of each that constitutes a drink (approximately 10 grams of pure ethanol). For example, one bottle of beer (330 ml at 5% ethanol), a glass of wine (140 ml at 12% ethanol), and a shot of spirits (40 ml at 40% ethanol) represent a standard drink of about 13 g of ethanol
Supplemental
Behavioral History
False
General (For all diseases)
General (For all diseases)
C00706
Alcohol prior use indicator
Indicator of the participant's/subject's alcohol consumption prior to the past 12 months
Supplemental
Behavioral History
False
General (For all diseases)
General (For all diseases)
C00730
Alcohol use frequency
The frequency of consumption of alcohol by the participant
Supplemental
Behavioral History
False
General (For all diseases)
General (For all diseases)
C00708
Alcohol use related to hospitalization indicator
Indicator of whether the participant/subject has been hospitalized for an alcohol-related problem (i.e., esophageal varices, delirium tremens (DTs), cirrhosis and others)
Supplemental
Behavioral History
False
General (For all diseases)
General (For all diseases)
C00702
Alcohol use started age value
Age in years when participant/subject started ingesting alcoholic beverages, including social drinking
Supplemental
Behavioral History
False
General (For all diseases)
General (For all diseases)
C00700
Alcohol use stopped age value
Age in years when participant/subject stopped ingesting alcoholic beverages, including social drinking
Supplemental
Behavioral History
False
General (For all diseases)
General (For all diseases)