Non Serious Adverse Drug Reactions Report

Start Date:2016-09-06 End Date:2016-09-07
Study :EMR700623-541Investigator :Ying ZhongCountry of Investigator :ChinaSiteNo:C05
Subject No :C05-0132Subject Initials :HQLDOB :07/16/1980Sex:FemaleRace:AsianHeight:166cmWeight:57kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment08/27/2015225
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS09/08/201509/16/2015RelatedMild
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
Disease under study**(Othervalue:)Dose not changedNoneResolved
Event Description:Abdominal distention,ultrasound prompt ascites,Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
ConditionStart DateRelated to study conditionOngoing
Fallopian tube repair anaplastyUK-Unk-2011Not on treatment/medication



07-SEP-16
Ying Zhong/EMR700623-541/C05-0132
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