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SERIOUS ADVERSE EVENT (SAE) REPORT FORM Guidelines …

SAE REPORT Form completion Guidelines 15-Dec-2015 Page 1 of 11 Author MSF PV unit Date 15-Dec-2015 Version SERIOUS ADVERSE EVENT (SAE) REPORT FORM Guidelines for completion SERIOUS ADVERSE EVENT (SAE) REPORT FORM Guidelines for completion SAE REPORT Form completion Guidelines 15-Dec-2015 Page 2 of 11 Table of content Table of content .. 2 List of abbreviations .. 3 1. Introduction .. 4 2 General instructions .. 5 3 Detailed instructions .. 6 Administrative information .. 6 Patient information .. 6 SERIOUS ADVERSE EVENT (s) information .. 6 Suspected drugs .. 8 Causality assessment .. 9 EVENT description .. 9 Relevant laboratory tests .. 10 Concomitant medications .. 10 Medical history .. 10 Reporter information .. 10 Case status and annexes .. 11 4 Special situation Parent/Child Foetus reports .. 11 5 References .. 11 SERIOUS ADVERSE EVENT (SAE) REPORT FORM Guidelines for completion SAE REPORT Form completion Guidelines 15-Dec-2015 Page 3 of 11 List of abbreviations AE ADVERSE EVENT CT Clinical trial DDI Drug-drug interaction ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use INN International Non-proprietary Name PV Pharmacovigilance SAE SERIOUS advers

SERIOUS ADVERSE EVENT (SAE) REPORT FORM Guidelines for completion SAE Report Form completion guidelines v.2.0– 15-Dec-2015 Page 7 of 11 The numbering (SAE 1, SAE 2, SAE 3) allows for causality assessment in section 3.5. Adverse event term for cases of overdose should be ZOverdose of [Drug name].

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PREGNANCY REPORT FORM Guidelines for completion

endtb.org

Pregnancy Report Form completion guidelines v.2.0 – 15-Dec-2015 Page 8 of 9 In the event of an SAE in the foetus/child (e.g. spina bifida), an SAE Report Form should record the serious child’s event with the patient being the child.

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