D
Patient Characteristics
Patient demographic and medical history
총 73개의 필드
D.1Patient (name or initials)Patient (name or initials)
AN필수
D.1.1.1Patient Medical Record Number(s) and Source(s) of the Record Number (GP Medical Record Number)Patient Medical Record Number(s) and Source(s) of the Record Number (GP Medical Record Number)
AN
D.1.1.2Patient Medical Record Number(s) and Source(s) of the Record Number (Specialist Record Number)Patient Medical Record Number(s) and Source(s) of the Record Number (Specialist Record Number)
AN
D.1.1.3Patient Medical Record Number(s) and Source(s) of the Record Number (Hospital Record Number)Patient Medical Record Number(s) and Source(s) of the Record Number (Hospital Record Number)
AN
D.1.1.4Patient Medical Record Number(s) and Source(s) of the Record Number (Investigation Number)Patient Medical Record Number(s) and Source(s) of the Record Number (Investigation Number)
AN
D.10.1Parent IdentificationParent Identification
AN
D.10.2.1Date of Birth of ParentDate of Birth of Parent
Date/Time
D.10.2.2AAge of Parent (number)Age of Parent (number)
N
D.10.2.2BAge of Parent (unit)Age of Parent (unit)
AN
D.10.3Last Menstrual Period Date of ParentLast Menstrual Period Date of Parent
Date/Time
D.10.4Body Weight (kg) of ParentBody Weight (kg) of Parent
N
D.10.5Height (cm) of ParentHeight (cm) of Parent
N
D.10.6Sex of ParentSex of Parent
N
D.10.7.1.R.1AMedDRA Version for Medical HistoryMedDRA Version for Medical History
AN
D.10.7.1.R.1BMedical History (disease / surgical procedure / etc.) (MedDRA code)Medical History (disease / surgical procedure / etc.) (MedDRA code)
N
D.10.7.1.R.2Start DateStart Date
Date/Time
D.10.7.1.R.3ContinuingContinuing
Boolean
D.10.7.1.R.4End DateEnd Date
Date/Time
D.10.7.1.R.5CommentsComments
AN
D.10.7.2Text for Relevant Medical History and Concurrent Conditions of ParentText for Relevant Medical History and Concurrent Conditions of Parent
AN
D.10.8.R.1Name of Drug as ReportedName of Drug as Reported
AN
D.10.8.R.1.KR.1AMedicinal Product VersionMedicinal Product Version
AN
D.10.8.R.1.KR.1BMedicinal Product IDMedicinal Product ID
AN
D.10.8.R.2AMPID Version Date/NumberMPID Version Date/Number
AN
D.10.8.R.2BMedicinal Product Identifier (MPID)Medicinal Product Identifier (MPID)
AN
D.10.8.R.3APhPID Version Date/NumberPhPID Version Date/Number
AN
D.10.8.R.3BPharmaceutical Product Identifier (PhPID)Pharmaceutical Product Identifier (PhPID)
AN
D.10.8.R.4Start DateStart Date
Date/Time
D.10.8.R.5End DateEnd Date
Date/Time
D.10.8.R.6AMedDRA Version for IndicationMedDRA Version for Indication
AN
D.10.8.R.6BIndication (MedDRA code)Indication (MedDRA code)
N
D.10.8.R.7AMedDRA Version for ReactionMedDRA Version for Reaction
AN
D.10.8.R.7BReactions (MedDRA code)Reactions (MedDRA code)
N
D.2.1Date of BirthDate of Birth
Date/Time
D.2.2.1AGestation Period When Reaction / Event Was Observed in the Foetus (number)Gestation Period When Reaction / Event Was Observed in the Foetus (number)
N
D.2.2.1BGestation Period When Reaction/Event Was Observed in the Foetus (unit)Gestation Period When Reaction/Event Was Observed in the Foetus (unit)
AN
D.2.2AAge at Time of Onset of Reaction / Event (number)Age at Time of Onset of Reaction / Event (number)
N
D.2.2BAge at Time of Onset of Reaction / Event (unit)Age at Time of Onset of Reaction / Event (unit)
AN
D.2.3Patient Age Group (as per reporter)Patient Age Group (as per reporter)
N
D.3Body Weight (kg)Body Weight (kg)
N
D.4Height (cm)Height (cm)
N
D.5SexSex
N
D.6Last Menstrual Period DateLast Menstrual Period Date
Date/Time
D.7.1.R.1AMedDRA Version for Medical HistoryMedDRA Version for Medical History
AN
D.7.1.R.1BMedical History (disease / surgical procedure / etc.) (MedDRA code)Medical History (disease / surgical procedure / etc.) (MedDRA code)
N
D.7.1.R.2Start DateStart Date
Date/Time
D.7.1.R.3ContinuingContinuing
Boolean
D.7.1.R.4End DateEnd Date
Date/Time
D.7.1.R.5CommentsComments
AN
D.7.1.R.6Family HistoryFamily History
Boolean
D.7.2Text for Relevant Medical History and Concurrent Conditions (not including reaction / event)Text for Relevant Medical History and Concurrent Conditions (not including reaction / event)
AN
D.7.3Concomitant TherapiesConcomitant Therapies
Boolean
D.8.R.1Name of Drug as ReportedName of Drug as Reported
AN
D.8.R.1.KR.1AMedicinal Product VersionMedicinal Product Version
AN
D.8.R.1.KR.1BMedicinal Product IDMedicinal Product ID
AN
D.8.R.2AMPID Version Date/NumberMPID Version Date/Number
AN
D.8.R.2BMedicinal Product Identifier (MPID)Medicinal Product Identifier (MPID)
AN
D.8.R.3APhPID Version Date/NumberPhPID Version Date/Number
AN
D.8.R.3BPharmaceutical Product Identifier (PhPID)Pharmaceutical Product Identifier (PhPID)
AN
D.8.R.4Start DateStart Date
Date/Time
D.8.R.5End DateEnd Date
Date/Time
D.8.R.6AMedDRA Version for IndicationMedDRA Version for Indication
AN
D.8.R.6BIndication (MedDRA code)Indication (MedDRA code)
N
D.8.R.7AMedDRA Version for ReactionMedDRA Version for Reaction
AN
D.8.R.7BReaction (MedDRA code)Reaction (MedDRA code)
N
D.9.1Date of DeathDate of Death
Date/Time
D.9.2.R.1AMedDRA Version for Reported Cause(s) of DeathMedDRA Version for Reported Cause(s) of Death
AN
D.9.2.R.1BReported Cause(s) of Death (MedDRA code)Reported Cause(s) of Death (MedDRA code)
N
D.9.2.R.2Reported Cause(s) of Death (free text)Reported Cause(s) of Death (free text)
AN
D.9.3Was Autopsy Done?Was Autopsy Done?
Boolean
D.9.4.R.1AMedDRA Version for Autopsy-determined Cause(s) of DeathMedDRA Version for Autopsy-determined Cause(s) of Death
AN
D.9.4.R.1BAutopsy-determined Cause(s) of Death (MedDRA code)Autopsy-determined Cause(s) of Death (MedDRA code)
N
D.9.4.R.2Autopsy-determined Cause(s) of Death (free text)Autopsy-determined Cause(s) of Death (free text)
AN