Non Serious Adverse Drug Reactions Report

Start Date:2016-07-11 End Date:2016-07-12
Study :EMR700623-541Investigator :NACountry of Investigator :KoreaSiteNo:K01
Subject No :k01-035Subject Initials :PSSDOB :01/19/1983Sex:FemaleRace:AsianHeight:161cmWeight:56g
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment03/11/2015225
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS03/23/201504/21/2015RelatedMild
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Dose not changedNoneResolved
Event Description: no addtional data
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:No
ConditionStart DateRelated to study conditionOngoing



11-JUL-16
NA/EMR700623-541/k01-035
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