Non Serious Adverse Drug Reactions Report

Start Date:2016-08-14 End Date:2016-08-15
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C04
Subject No :C04-0171Subject Initials :SHLDOB :08/17/1987Sex:FemaleRace:AsianHeight:154cmWeight:40kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment09/29/2015300
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS09/30/201510/09/2015RelatedMild
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Dose reducedNoneResolved
Event Description:none
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:No
ConditionStart DateRelated to study conditionOngoing



14-AUG-16
NA/EMR700623-541/C04-0171
Page 1 of9