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)
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)
C02309
Serious adverse event indicator
The indicator of whether the adverse event is serious.
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)
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)
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)
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)
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)
C18659
Unexpected adverse event indicator
The indicator of whether the adverse event is unexpected
Supplemental
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)
C22702
Institutional review board notification indicator
Indicator of whether the Institutional Review Board (IRB) was notified following an 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)
C22703
Serious adverse event form completion indicator
Indicator of whether the Serious Adverse Event (SAE) form was completed following an adverse event
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)
C00701
Tobacco use stopped age value
Age in years when participant/subject stopped using tobacco products (e.g., cigarettes, cigars, chewing tobacco or pipe)
Supplemental
Behavioral History
False
General (For all diseases)
General (For all diseases)
C00709
Tobacco cigarettes smoked daily average number
Average number of cigarettes the participant/subject smokes daily (On the days you smoked cigarettes during the past 30 days, how many cigarettes did you smoke per day, on average?)
Supplemental
Behavioral History
False
General (For all diseases)
General (For all diseases)
C18670
Subscribed drug or substance illicitly used category other text
The free-text field related to 'Subscribed drug or substance illicitly used category' specifying other text. Category of illegal drugs, prescription, or over-the-counter drugs the participant/subject used for purposes other than those for which they are meant to be used, or in large amounts
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)
C00710
Tobacco current use indicator
Indicator for whether the participant/subject regularly uses tobacco products (e.g., cigarettes, cigars, chewing tobacco or pipe) at the present time
Supplemental
Behavioral History
False
General (For all diseases)
General (For all diseases)
C18770
Tobacco product used other text
The free-text field related to 'Tobacco product used type' specifying other text. Type of tobacco product (e.g. cigarettes, cigars, chewing tobacco or pipe) used by the participant/subject
Supplemental
Behavioral History
False
General (For all diseases)
General (For all diseases)
C00703
Tobacco use started age value
Age in years when participant/subject started using tobacco products (e.g., cigarettes, cigars, chewing tobacco or pipe)
Supplemental
Behavioral History
False
General (For all diseases)
General (For all diseases)
C00711
Tobacco prior use indicator
Indicator of the participant's/subject's past regular tobacco (e.g., cigarettes, cigars, chewing tobacco or pipe) use prior to 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)
C00712
Subscribed drug or substance illicitly used category
Category of illegal drugs, prescription, or over-the-counter drugs subscribed by the participant/subject, and used for purposes other than those for which they are meant to be used, or in large amounts
Supplemental
Behavioral History
False
General (For all diseases)
General (For all diseases)