Non Serious Adverse Drug Reactions Report

Start Date:2016-07-25 End Date:2016-07-26
Study :EMR700623-541Investigator :Fei GongCountry of Investigator :ChinaSiteNo:C01
Subject No :C01-0158Subject Initials :T-YDOB :06/17/1983Sex:FemaleRace:AsianHeight:163cmWeight:3300g
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment09/16/2015112.5
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS10/12/201510/12/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableConcomitant procedure**Resolved
Event Description:Abdominal distension, Nausea, yellow urine with less volume, chest pelvic effusion,ascites puncture 12-Oct-2015,2500ml
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
ConditionStart DateRelated to study conditionOngoing
right fallopian tube is less patency,left fallopian tube is obstruction06/04/2015Not on treatment/medicationOngoing
Endometrial polyps hyperplasia08/24/2015Not on treatment/medicationOngoing



26-JUL-16
Fei Gong/EMR700623-541/C01-0158
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