ICSR Atlas
G

Drug Information

Drug/substance information

총 61개의 필드

G.K.1Characterisation of Drug Role
Characterisation of Drug Role
G.K.10.RAdditional Information on Drug (coded) (repeat as necessary)
Additional Information on Drug (coded) (repeat as necessary)
G.K.11Additional Information on Drug (free text)
Additional Information on Drug (free text)
G.K.2.1.1AMPID Version Date / Number
MPID Version Date / Number
G.K.2.1.1BMedicinal Product Identifier (MPID)
Medicinal Product Identifier (MPID)
G.K.2.1.2APhPID Version Date/Number
PhPID Version Date/Number
G.K.2.1.2BPharmaceutical Product Identifier (PhPID)
Pharmaceutical Product Identifier (PhPID)
G.K.2.1.KR.1AMedicinal Product Version
Medicinal Product Version
G.K.2.1.KR.1BMedicinal Product ID
Medicinal Product ID
G.K.2.2Medicinal Product Name as Reported by the Primary Source
Medicinal Product Name as Reported by the Primary Source
G.K.2.3.R.1Substance / Specified Substance Name
Substance / Specified Substance Name
G.K.2.3.R.1.KR.1ASubstance Version
Substance Version
G.K.2.3.R.1.KR.1BSubstance ID
Substance ID
G.K.2.3.R.2ASubstance/Specified Substance TermID Version Date/Number
Substance/Specified Substance TermID Version Date/Number
G.K.2.3.R.2BSubstance/Specified Substance TermID
Substance/Specified Substance TermID
G.K.2.3.R.3AStrength (number)
Strength (number)
G.K.2.3.R.3BStrength (unit)
Strength (unit)
G.K.2.4Identification of the Country Where the Drug Was Obtained
Identification of the Country Where the Drug Was Obtained
G.K.2.5Investigational Product Blinded
Investigational Product Blinded
G.K.3.1Authorisation / Application Number
Authorisation / Application Number
G.K.3.2Country of Authorisation / Application
Country of Authorisation / Application
G.K.3.3Name of Holder / Applicant
Name of Holder / Applicant
G.K.4.R.10.1Route of Administration (free text)
Route of Administration (free text)
G.K.4.R.10.2ARoute of Administration TermID Version Date / Number
Route of Administration TermID Version Date / Number
G.K.4.R.10.2BRoute of Administration TermID
Route of Administration TermID
G.K.4.R.11.1Parent Route of Administration (free text)
Parent Route of Administration (free text)
G.K.4.R.11.2AParent Route of Administration TermID Version Date / Number
Parent Route of Administration TermID Version Date / Number
G.K.4.R.11.2BParent Route of Administration TermID
Parent Route of Administration TermID
G.K.4.R.1ADose (number)
Dose (number)
G.K.4.R.1BDose (unit)
Dose (unit)
G.K.4.R.2Number of Units in the Interval
Number of Units in the Interval
G.K.4.R.3Definition of the Time Interval Unit
Definition of the Time Interval Unit
G.K.4.R.4Date and Time of Start of Drug
Date and Time of Start of Drug
G.K.4.R.5Date and Time of Last Administration
Date and Time of Last Administration
G.K.4.R.6ADuration of Drug Administration (number)
Duration of Drug Administration (number)
G.K.4.R.6BDuration of Drug Administration (unit)
Duration of Drug Administration (unit)
G.K.4.R.7Batch / Lot Number
Batch / Lot Number
G.K.4.R.8Dosage Text
Dosage Text
G.K.4.R.9.1Pharmaceutical Dose Form (free text)
Pharmaceutical Dose Form (free text)
G.K.4.R.9.2APharmaceutical Dose Form TermID Version Date/Number
Pharmaceutical Dose Form TermID Version Date/Number
G.K.4.R.9.2BPharmaceutical Dose Form TermID
Pharmaceutical Dose Form TermID
G.K.5ACumulative Dose to First Reaction (number)
Cumulative Dose to First Reaction (number)
G.K.5BCumulative Dose to First Reaction (unit)
Cumulative Dose to First Reaction (unit)
G.K.6AGestation Period at Time of Exposure (number)
Gestation Period at Time of Exposure (number)
G.K.6BGestation Period at Time of Exposure (unit)
Gestation Period at Time of Exposure (unit)
G.K.7.R.1Indication as Reported by the Primary Source
Indication as Reported by the Primary Source
G.K.7.R.2AMedDRA Version for Indication
MedDRA Version for Indication
G.K.7.R.2BIndication (MedDRA code)
Indication (MedDRA code)
G.K.8Action(s) Taken with Drug
Action(s) Taken with Drug
G.K.9.I.1Reaction(s) / Event(s) Assessed
Reaction(s) / Event(s) Assessed
G.K.9.I.2.R.1Source of Assessment
Source of Assessment
G.K.9.I.2.R.2Method of Assessment
Method of Assessment
G.K.9.I.2.R.2.KR.1KR Method of Assessment
KR Method of Assessment
G.K.9.I.2.R.3Result of Assessment
Result of Assessment
G.K.9.I.2.R.3.KR.1WHO-UMC Result of Assessment
WHO-UMC Result of Assessment
G.K.9.I.2.R.3.KR.2KRCT Result of Assessment
KRCT Result of Assessment
G.K.9.I.3.1ATime Interval between Beginning of Drug Administration and Start of Reaction / Event (number)
Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number)
G.K.9.I.3.1BTime Interval between Beginning of Drug Administration and Start of Reaction / Event (unit)
Time Interval between Beginning of Drug Administration and Start of Reaction / Event (unit)
G.K.9.I.3.2ATime Interval between Last Dose of Drug and Start of Reaction / Event (number)
Time Interval between Last Dose of Drug and Start of Reaction / Event (number)
G.K.9.I.3.2BTime Interval between Last Dose of Drug and Start of Reaction / Event (unit)
Time Interval between Last Dose of Drug and Start of Reaction / Event (unit)
G.K.9.I.4Did Reaction Recur on Re-administration?
Did Reaction Recur on Re-administration?