Non Serious Adverse Drug Reactions Report

Start Date:2016-03-31 End Date:2016-04-01
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0161Subject Initials :H-YDOB :12/12/1985Sex:FemaleRace:AsianHeight:166cmWeight:57.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/26/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/10/201506/16/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
ConditionStart DateRelated to study conditionOngoing
HSG: bilateral tubal obstruction Uk-Unk-2007Not on treatment/medication
Laparoscopic tubal surgery sticking points. Uk-Unk-2007Not on treatment/medication
Open left fallopian tube ectopic pregnancy surgeryUk-Unk-2012Not on treatment/medication



31-MAR-16
NA/EMR700623-541/C02-0161
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