Non Serious Adverse Drug Reactions Report

Start Date:2015-10-21 End Date:2015-10-22
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0111Subject Initials :CXWDOB :10/10/1979Sex:FemaleRace:AsianHeight:162cmWeight:68.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/20/2015200
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSSRelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:Moderate OHSS patients, improved canceled after embryo transfer.
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
ConditionStart DateRelated to study conditionOngoing
Ectopic pregnancy laparoscopic surgery, the left fallopian tube embryo window.Uk-Unk-2012Not on treatment/medication
Tubal lipiodol angiographyUk-Unk-2013Not on treatment/medication



21-OCT-15
NA/EMR700623-541/C02-0111
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