Non Serious Adverse Drug Reactions Report

Start Date:2016-09-12 End Date:2016-09-13
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0201Subject Initials :J-LDOB :12/15/1990Sex:FemaleRace:AsianHeight:168cmWeight:65kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment09/07/2015125
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS09/24/201510/02/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
ConditionStart DateRelated to study conditionOngoing
HSG: bilateral tubal occlusionUk-Unk-2012Not on treatment/medication



12-SEP-16
NA/EMR700623-541/C02-0201
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Non Serious Adverse Drug Reactions Report

Start Date:2016-09-12 End Date:2016-09-13
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
OHSS10/03/201510/10/2015RelatedMild
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



12-SEP-16
NA/EMR700623-541/C04-0171
Page 2 of8