ICSR AtlasFor PV Professionals

개별 이상사례 전자보고양식[E2B(R3)] 가이드라인(2016)

작성: 2016-03고시: 2017-06
N.1.1Types of Message in batchN.1.2Batch NumberN.1.3Batch Sender IdentifierN.1.4Batch Receiver IdentifierN.1.5Date of Batch TransmissionN.2.R.1Message IdentifierN.2.R.2Message Sender IdentifierN.2.R.3Message Receiver IdentifierN.2.R.4Date of Message Creation
C.1.1Sender’s (case) Safety Report Unique IdentifierC.1.2Date of CreationC.1.3Type of ReportC.1.4Date Report Was First Received from SourceC.1.5Date of Most Recent Information for This ReportC.1.6.1Are Additional Documents Available?C.1.6.1.R.1Documents Held by SenderC.1.6.1.R.2Included DocumentsC.1.7Does This Case Fulfil the Local Criteria for an Expedited Report?C.1.8.1Worldwide Unique Case IdentificationC.1.8.2First Sender of This CaseC.1.9.1Other Case Identifiers in Previous TransmissionsC.1.9.1.R.1Source(s) of the Case IdentifierC.1.9.1.R.2Case Identifier(s)C.1.10.RIdentification Number of the Report Which Is Linked to This Report C.1.11.1Report Nullification / AmendmentC.1.11.2Reason for Nullification / Amendment
C.2.R.1.1Reporter’s TitleC.2.R.1.2Reporter’s Given NameC.2.R.1.3Reporter’s Middle NameC.2.R.1.4Reporter’s Family NameC.2.R.2.1Reporter’s OrganisationC.2.R.2.2Reporter’s DepartmentC.2.R.2.3Reporter’s StreetC.2.R.2.4Reporter’s CityC.2.R.2.5Reporter’s State or ProvinceC.2.R.2.6Reporter’s PostcodeC.2.R.2.7Reporter’s TelephoneC.2.R.3Reporter’s Country CodeC.2.R.4QualificationC.2.R.4.KR.1Other Health professional TypeC.2.R.5Primary Source for Regulatory Purposes
C.3.1Sender TypeC.3.1.KR.1Health Professional TypeC.3.2Sender’s OrganisationC.3.3.1Sender’s DepartmentC.3.3.2Sender’s TitleC.3.3.3Sender’s Given NameC.3.3.4Sender’s Middle NameC.3.3.5Sender’s Family NameC.3.4.1Sender’s Street AddressC.3.4.2Sender’s CityC.3.4.3Sender’s State or ProvinceC.3.4.4Sender’s PostcodeC.3.4.5Sender’s Country CodeC.3.4.6Sender’s TelephoneC.3.4.7Sender’s FaxC.3.4.8Sender’s E-mail Address
C.4.R.1Literature Reference(s)C.4.R.2Included Documents
C.5.1.R.1Study Registration NumberC.5.1.R.2Study Registration CountryC.5.2Study NameC.5.3Sponsor Study NumberC.5.4Study Type Where Reaction(s) / Event(s) Were ObservedC.5.4.KR.1Other Studies Type
D.1Patient (name or initials)D.1.1.1Patient Medical Record Number(s) and Source(s) of the Record Number (GP Medical Record Number)D.1.1.2Patient Medical Record Number(s) and Source(s) of the Record Number (Specialist Record Number)D.1.1.3Patient Medical Record Number(s) and Source(s) of the Record Number (Hospital Record Number)D.1.1.4Patient Medical Record Number(s) and Source(s) of the Record Number (Investigation Number)D.2.1Date of BirthD.2.2.1AGestation Period When Reaction / Event Was Observed in the Foetus (number)D.2.2.1BGestation Period When Reaction/Event Was Observed in the Foetus (unit)D.2.2AAge at Time of Onset of Reaction / Event (number)D.2.2BAge at Time of Onset of Reaction / Event (unit)D.2.3Patient Age Group (as per reporter)D.3Body Weight (kg)D.4Height (cm)D.5SexD.6Last Menstrual Period DateD.7.1.R.1AMedDRA Version for Medical HistoryD.7.1.R.1BMedical History (disease / surgical procedure / etc.) (MedDRA code)D.7.1.R.2Start DateD.7.1.R.3ContinuingD.7.1.R.4End DateD.7.1.R.5CommentsD.7.1.R.6Family HistoryD.7.2Text for Relevant Medical History and Concurrent Conditions (not including reaction / event)D.7.3Concomitant TherapiesD.8.R.1Name of Drug as ReportedD.8.R.1.KR.1AMedicinal Product VersionD.8.R.1.KR.1BMedicinal Product IDD.8.R.2AMPID Version Date/NumberD.8.R.2BMedicinal Product Identifier (MPID)D.8.R.3APhPID Version Date/NumberD.8.R.3BPharmaceutical Product Identifier (PhPID)D.8.R.4Start DateD.8.R.5End DateD.8.R.6AMedDRA Version for IndicationD.8.R.6BIndication (MedDRA code)D.8.R.7AMedDRA Version for ReactionD.8.R.7BReaction (MedDRA code)D.9.1Date of DeathD.9.2.R.1AMedDRA Version for Reported Cause(s) of DeathD.9.2.R.1BReported Cause(s) of Death (MedDRA code)D.9.2.R.2Reported Cause(s) of Death (free text)D.9.3Was Autopsy Done?D.9.4.R.1AMedDRA Version for Autopsy-determined Cause(s) of DeathD.9.4.R.1BAutopsy-determined Cause(s) of Death (MedDRA code)D.9.4.R.2Autopsy-determined Cause(s) of Death (free text)D.10.1Parent IdentificationD.10.2.1Date of Birth of ParentD.10.2.2AAge of Parent (number)D.10.2.2BAge of Parent (unit)D.10.3Last Menstrual Period Date of ParentD.10.4Body Weight (kg) of ParentD.10.5Height (cm) of ParentD.10.6Sex of ParentD.10.7.1.R.1AMedDRA Version for Medical HistoryD.10.7.1.R.1BMedical History (disease / surgical procedure / etc.) (MedDRA code)D.10.7.1.R.2Start DateD.10.7.1.R.3ContinuingD.10.7.1.R.4End DateD.10.7.1.R.5CommentsD.10.7.2Text for Relevant Medical History and Concurrent Conditions of ParentD.10.8.R.1Name of Drug as ReportedD.10.8.R.1.KR.1AMedicinal Product VersionD.10.8.R.1.KR.1BMedicinal Product IDD.10.8.R.2AMPID Version Date/NumberD.10.8.R.2BMedicinal Product Identifier (MPID)D.10.8.R.3APhPID Version Date/NumberD.10.8.R.3BPharmaceutical Product Identifier (PhPID)D.10.8.R.4Start DateD.10.8.R.5End DateD.10.8.R.6AMedDRA Version for IndicationD.10.8.R.6BIndication (MedDRA code)D.10.8.R.7AMedDRA Version for ReactionD.10.8.R.7BReactions (MedDRA code)
E.I.1.1AReaction / Event as Reported by the Primary Source in Native LanguageE.I.1.1BReaction / Event as Reported by the Primary Source LanguageE.I.1.2Reaction / Event as Reported by the Primary Source for TranslationE.I.2.1AMedDRA Version for Reaction / EventE.I.2.1BReaction / Event (MedDRA code)E.I.3.1Term Highlighted by the ReporterE.I.3.2AResults in DeathE.I.3.2BLife ThreateningE.I.3.2CCaused / Prolonged HospitalisationE.I.3.2DDisabling / IncapacitatingE.I.3.2ECongenital Anomaly / Birth DefectE.I.3.2FOther Medically Important ConditionE.I.4Date of Start of Reaction / EventE.I.5Date of End of Reaction / EventE.I.6ADuration of Reaction / Event (number)E.I.6BDuration of Reaction / Event (unit)E.I.7Outcome of Reaction / Event at the Time of Last ObservationE.I.8Medical Confirmation by Healthcare ProfessionalE.I.9Identification of the Country Where the Reaction / Event Occurred
F.R.1Test DateF.R.2.1Test Name (free text)F.R.2.2AMedDRA Version for Test NameF.R.2.2BTest Name (MedDRA code)F.R.3.1Test Result (code)F.R.3.2Test Result (value / qualifier)F.R.3.3Test Result (unit)F.R.3.4Result Unstructured Data (free text)F.R.4Normal Low ValueF.R.5Normal High ValueF.R.6Comments (free text)F.R.7More Information Available
G.K.1Characterisation of Drug RoleG.K.2.1.1AMPID Version Date / NumberG.K.2.1.1BMedicinal Product Identifier (MPID) G.K.2.1.2APhPID Version Date/NumberG.K.2.1.2BPharmaceutical Product Identifier (PhPID)G.K.2.1.KR.1AMedicinal Product VersionG.K.2.1.KR.1BMedicinal Product IDG.K.2.2Medicinal Product Name as Reported by the Primary SourceG.K.2.3.R.1Substance / Specified Substance NameG.K.2.3.R.1.KR.1ASubstance VersionG.K.2.3.R.1.KR.1BSubstance IDG.K.2.3.R.2ASubstance/Specified Substance TermID Version Date/NumberG.K.2.3.R.2BSubstance/Specified Substance TermIDG.K.2.3.R.3AStrength (number) G.K.2.3.R.3BStrength (unit)G.K.2.4Identification of the Country Where the Drug Was ObtainedG.K.2.5Investigational Product BlindedG.K.3.1Authorisation / Application NumberG.K.3.2Country of Authorisation / ApplicationG.K.3.3Name of Holder / ApplicantG.K.4.R.1ADose (number)G.K.4.R.1BDose (unit)G.K.4.R.2Number of Units in the IntervalG.K.4.R.3Definition of the Time Interval UnitG.K.4.R.4Date and Time of Start of DrugG.K.4.R.5Date and Time of Last AdministrationG.K.4.R.6ADuration of Drug Administration (number)G.K.4.R.6BDuration of Drug Administration (unit)G.K.4.R.7Batch / Lot NumberG.K.4.R.8Dosage TextG.K.4.R.9.1Pharmaceutical Dose Form (free text)G.K.4.R.9.2APharmaceutical Dose Form TermID Version Date/NumberG.K.4.R.9.2BPharmaceutical Dose Form TermIDG.K.4.R.10.1Route of Administration (free text)G.K.4.R.10.2ARoute of Administration TermID Version Date / NumberG.K.4.R.10.2BRoute of Administration TermIDG.K.4.R.11.1Parent Route of Administration (free text)G.K.4.R.11.2AParent Route of Administration TermID Version Date / NumberG.K.4.R.11.2BParent Route of Administration TermIDG.K.5ACumulative Dose to First Reaction (number)G.K.5BCumulative Dose to First Reaction (unit)G.K.6AGestation Period at Time of Exposure (number)G.K.6BGestation Period at Time of Exposure (unit)G.K.7.R.1Indication as Reported by the Primary SourceG.K.7.R.2AMedDRA Version for IndicationG.K.7.R.2BIndication (MedDRA code)G.K.8Action(s) Taken with DrugG.K.9.I.1Reaction(s) / Event(s) AssessedG.K.9.I.2.R.1Source of AssessmentG.K.9.I.2.R.2Method of AssessmentG.K.9.I.2.R.2.KR.1KR Method of AssessmentG.K.9.I.2.R.3Result of AssessmentG.K.9.I.2.R.3.KR.1WHO-UMC Result of AssessmentG.K.9.I.2.R.3.KR.2KRCT Result of AssessmentG.K.9.I.3.1ATime 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)G.K.9.I.3.2ATime 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)G.K.9.I.4Did Reaction Recur on Re-administration?G.K.10.RAdditional Information on Drug (coded) (repeat as necessary)G.K.11Additional Information on Drug (free text)
H.1Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant InformationH.2Reporter's CommentsH.3.R.1AMedDRA Version for Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / EventH.3.R.1BSender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event (MedDRA code)H.4Sender's CommentsH.5.R.1ACase Summary and Reporter’s Comments TextH.5.R.1BCase Summary and Reporter’s Comments Language

ICSR Atlas v1.0  ·  237 fields

  1. ICSR Atlas
  2. D Patient Characteristics
  3. D.2.2A
ICSR Field Reference

Age at Time of Onset of Reaction / Event (number)

Age at Time of Onset of Reaction / Event (number)

SectionD Patient Characteristics
Data TypeN
RequiredNo
Data Last UpdatedJune 15, 2026

1.Field Definition

Element NumberD.2.2A
Element NameAge at Time of Onset of Reaction / Event (number)
English NameAge at Time of Onset of Reaction / Event (number) (Age at Time of Onset of Reaction / Event (number))
Data TypeNumeric
Max Length5
RequiredNo
Allowed ValuesNumeric

Allowed Null Flavors

No null flavors allowed

2.User Guidance

Enter the numeric value of the patient's age at the time of onset of the reaction/event. If there are multiple reactions/events, the age at the time of onset of the first reaction/event should be provided. For a foetus, use D.2.2.1 (gestation period) instead. Care should be taken when expressing age in decades (e.g. the 7th decade represents a patient in their 60s).

3.Validation Rules

Conditional Rules

If (Condition)

Value Exists
D.2.2B

Then (Result)

Required
Yes