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Identification of the case safety report |
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Primary source(s) of information |
Sender Information |
Receiver Information |
B.1 Patient Includes B.1.7.2 and Patient characteristics
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A.1.11.1 and Source(s) of the case identifier & Case identifier(s) |
Identification number of the report which is linked to this report |
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B.1.7.1 Medical History Episode Relevant medical history and concurrent |
B.1.8 Patient Past Drug Therapy Relevant past drug history |
In case of death |
Includes B.1.10.7.2 For a parent-child / fetus report, information concerning the parent |
Reaction(s) / Event(s) |
Results of tests and procedures relevant to the investigation of the patient |
Drug Information |
Narrative case summary and further information |
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B.1.9.2Patient Death Cause |
In case of death |
B.1.10.7.1 Parent Medical History Episode Relevant medical history and concurrent conditions of parent |
B.1.10.8 Parent Past Drug Therapy Relevant past drug history |
Active drug substance names |
If yes, which reaction/event recurred? |
B.4.k.18 Drug Reaction Relatedness Relatedness of drug to reaction / event |
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