Non Serious Adverse Drug Reactions Report

Start Date:2016-07-19 End Date:2016-07-20
Study :EMR700623-541Investigator :Fei GongCountry of Investigator :ChinaSiteNo:C01
Subject No :C01-0001Subject Initials :TTWDOB :05/13/1988Sex:FemaleRace:AsianHeight:157cmWeight:3050g
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/16/2015112.5
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/06/201506/15/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableConcomitant procedure**Resolved
Event Description:Nausea, vomiting, yellow urine with less volume, chest pelvic effusion,ascites puncture 10-Jun-2015,2200ml;ascites puncture 15-Jun-2015,2900ml;
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
ConditionStart DateRelated to study conditionOngoing
Bilateral fallopian tube obstruction04/11/2014Not on treatment/medicationOngoing



19-JUL-16
Fei Gong/EMR700623-541/C01-0001
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