Non Serious Adverse Drug Reactions Report

Start Date:2015-07-02 End Date:2015-07-06
Study :EMR700623-541Investigator :NACountry of Investigator :KoreaSiteNo:K01
Subject No :k01-0059Subject Initials :LKHDOB :08/05/1981Sex:FemaleRace:AsianHeight:153cmWeight:74kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment06/02/2015225
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/13/201507/02/2015RelatedMild
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Dose not changedLed to study terminationResolved
Event description:
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:No
ConditionStart DateRelated to study conditionOngoing
 



06-JUL-15
NA/EMR700623-541/k01-0059
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