FDA.G.K.12.R.7.1E - Evaluation Summary

Regulatory Agency

개별 이상사례 전자보고양식[E2B(R3)] 가이드라인(2016)

작성: 2016-03고시: 2017-06

Field Search

N.1.1Types of Message in batch N.1.2Batch Number N.1.3Batch Sender Identifier N.1.4Batch Receiver Identifier N.1.5Date of Batch Transmission N.2.R.1Message Identifier N.2.R.2Message Sender Identifier N.2.R.3Message Receiver Identifier N.2.R.4Date of Message Creation

C.1.1Sender’s (case) Safety Report Unique Identifier C.1.2Date of Creation C.1.3Type of Report C.1.4Date Report Was First Received from Source C.1.5Date of Most Recent Information for This Report C.1.6.1Are Additional Documents Available?C.1.6.1.R.1Documents Held by Sender C.1.6.1.R.2Included Documents C.1.7Does This Case Fulfil the Local Criteria for an Expedited Report?C.1.8.1Worldwide Unique Case Identification C.1.8.2First Sender of This Case C.1.9.1Other Case Identifiers in Previous Transmissions C.1.9.1.R.1Source(s) of the Case Identifier C.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 / Amendment C.1.11.2Reason for Nullification / Amendment

C.2.R.1.1Reporter’s Title C.2.R.1.2Reporter’s Given Name C.2.R.1.3Reporter’s Middle Name C.2.R.1.4Reporter’s Family Name C.2.R.2.1Reporter’s Organisation C.2.R.2.2Reporter’s Department C.2.R.2.3Reporter’s Street C.2.R.2.4Reporter’s City C.2.R.2.5Reporter’s State or Province C.2.R.2.6Reporter’s Postcode C.2.R.2.7Reporter’s Telephone C.2.R.3Reporter’s Country Code C.2.R.4Qualification C.2.R.4.KR.1Other Health professional Type C.2.R.5Primary Source for Regulatory Purposes

C.3.1Sender Type C.3.1.KR.1Health Professional Type C.3.2Sender’s Organisation C.3.3.1Sender’s Department C.3.3.2Sender’s Title C.3.3.3Sender’s Given Name C.3.3.4Sender’s Middle Name C.3.3.5Sender’s Family Name C.3.4.1Sender’s Street Address C.3.4.2Sender’s City C.3.4.3Sender’s State or Province C.3.4.4Sender’s Postcode C.3.4.5Sender’s Country Code C.3.4.6Sender’s Telephone C.3.4.7Sender’s Fax C.3.4.8Sender’s E-mail Address

C.4.R.1Literature Reference(s)C.4.R.2Included Documents

C.5.1.R.1Study Registration Number C.5.1.R.2Study Registration Country C.5.2Study Name C.5.3Sponsor Study Number C.5.4Study Type Where Reaction(s) / Event(s) Were Observed C.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 Birth D.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.5Sex D.6Last Menstrual Period Date D.7.1.R.1AMedDRA Version for Medical History D.7.1.R.1BMedical History (disease / surgical procedure / etc.) (MedDRA code)D.7.1.R.2Start Date D.7.1.R.3Continuing D.7.1.R.4End Date D.7.1.R.5Comments D.7.1.R.6Family History D.7.2Text for Relevant Medical History and Concurrent Conditions (not including reaction / event)D.7.3Concomitant Therapies D.8.R.1Name of Drug as Reported D.8.R.1.KR.1AMedicinal Product Version D.8.R.1.KR.1BMedicinal Product ID D.8.R.2AMPID Version Date/Number D.8.R.2BMedicinal Product Identifier (MPID)D.8.R.3APhPID Version Date/Number D.8.R.3BPharmaceutical Product Identifier (PhPID)D.8.R.4Start Date D.8.R.5End Date D.8.R.6AMedDRA Version for Indication D.8.R.6BIndication (MedDRA code)D.8.R.7AMedDRA Version for Reaction D.8.R.7BReaction (MedDRA code)D.9.1Date of Death D.9.2.R.1AMedDRA Version for Reported Cause(s) of Death D.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 Death D.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 Identification D.10.2.1Date of Birth of Parent D.10.2.2AAge of Parent (number)D.10.2.2BAge of Parent (unit)D.10.3Last Menstrual Period Date of Parent D.10.4Body Weight (kg) of Parent D.10.5Height (cm) of Parent D.10.6Sex of Parent D.10.7.1.R.1AMedDRA Version for Medical History D.10.7.1.R.1BMedical History (disease / surgical procedure / etc.) (MedDRA code)D.10.7.1.R.2Start Date D.10.7.1.R.3Continuing D.10.7.1.R.4End Date D.10.7.1.R.5Comments D.10.7.2Text for Relevant Medical History and Concurrent Conditions of Parent D.10.8.R.1Name of Drug as Reported D.10.8.R.1.KR.1AMedicinal Product Version D.10.8.R.1.KR.1BMedicinal Product ID D.10.8.R.2AMPID Version Date/Number D.10.8.R.2BMedicinal Product Identifier (MPID)D.10.8.R.3APhPID Version Date/Number D.10.8.R.3BPharmaceutical Product Identifier (PhPID)D.10.8.R.4Start Date D.10.8.R.5End Date D.10.8.R.6AMedDRA Version for Indication D.10.8.R.6BIndication (MedDRA code)D.10.8.R.7AMedDRA Version for Reaction D.10.8.R.7BReactions (MedDRA code)

E.I.1.1AReaction / Event as Reported by the Primary Source in Native Language E.I.1.1BReaction / Event as Reported by the Primary Source Language E.I.1.2Reaction / Event as Reported by the Primary Source for Translation E.I.2.1AMedDRA Version for Reaction / Event E.I.2.1BReaction / Event (MedDRA code)E.I.3.1Term Highlighted by the Reporter E.I.3.2AResults in Death E.I.3.2BLife Threatening E.I.3.2CCaused / Prolonged Hospitalisation E.I.3.2DDisabling / Incapacitating E.I.3.2ECongenital Anomaly / Birth Defect E.I.3.2FOther Medically Important Condition E.I.4Date of Start of Reaction / Event E.I.5Date of End of Reaction / Event E.I.6ADuration of Reaction / Event (number)E.I.6BDuration of Reaction / Event (unit)E.I.7Outcome of Reaction / Event at the Time of Last Observation E.I.8Medical Confirmation by Healthcare Professional E.I.9Identification of the Country Where the Reaction / Event Occurred

F.R.1Test Date F.R.2.1Test Name (free text)F.R.2.2AMedDRA Version for Test Name F.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 Value F.R.5Normal High Value F.R.6Comments (free text)F.R.7More Information Available

G.K.1Characterisation of Drug Role G.K.2.1.1AMPID Version Date / Number G.K.2.1.1BMedicinal Product Identifier (MPID) G.K.2.1.2APhPID Version Date/Number G.K.2.1.2BPharmaceutical Product Identifier (PhPID)G.K.2.1.KR.1AMedicinal Product Version G.K.2.1.KR.1BMedicinal Product ID G.K.2.2Medicinal Product Name as Reported by the Primary Source G.K.2.3.R.1Substance / Specified Substance Name G.K.2.3.R.1.KR.1ASubstance Version G.K.2.3.R.1.KR.1BSubstance ID G.K.2.3.R.2ASubstance/Specified Substance TermID Version Date/Number G.K.2.3.R.2BSubstance/Specified Substance TermID G.K.2.3.R.3AStrength (number) G.K.2.3.R.3BStrength (unit)G.K.2.4Identification of the Country Where the Drug Was Obtained G.K.2.5Investigational Product Blinded G.K.3.1Authorisation / Application Number G.K.3.2Country of Authorisation / Application G.K.3.3Name of Holder / Applicant G.K.4.R.1ADose (number)G.K.4.R.1BDose (unit)G.K.4.R.2Number of Units in the Interval G.K.4.R.3Definition of the Time Interval Unit G.K.4.R.4Date and Time of Start of Drug G.K.4.R.5Date and Time of Last Administration G.K.4.R.6ADuration of Drug Administration (number)G.K.4.R.6BDuration of Drug Administration (unit)G.K.4.R.7Batch / Lot Number G.K.4.R.8Dosage Text G.K.4.R.9.1Pharmaceutical Dose Form (free text)G.K.4.R.9.2APharmaceutical Dose Form TermID Version Date/Number G.K.4.R.9.2BPharmaceutical Dose Form TermID G.K.4.R.10.1Route of Administration (free text)G.K.4.R.10.2ARoute of Administration TermID Version Date / Number G.K.4.R.10.2BRoute of Administration TermID G.K.4.R.11.1Parent Route of Administration (free text)G.K.4.R.11.2AParent Route of Administration TermID Version Date / Number G.K.4.R.11.2BParent Route of Administration TermID G.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 Source G.K.7.R.2AMedDRA Version for Indication G.K.7.R.2BIndication (MedDRA code)G.K.8Action(s) Taken with Drug G.K.9.I.1Reaction(s) / Event(s) Assessed G.K.9.I.2.R.1Source of Assessment G.K.9.I.2.R.2Method of Assessment G.K.9.I.2.R.2.KR.1KR Method of Assessment G.K.9.I.2.R.3Result of Assessment G.K.9.I.2.R.3.KR.1WHO-UMC Result of Assessment G.K.9.I.2.R.3.KR.2KRCT Result of Assessment G.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 Information H.2Reporter's Comments H.3.R.1AMedDRA Version for Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event H.3.R.1BSender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event (MedDRA code)H.4Sender's Comments H.5.R.1ACase Summary and Reporter’s Comments Text H.5.R.1BCase Summary and Reporter’s Comments Language

ICSR Atlas v1.0 · 237 fields