Non Serious Adverse Drug Reactions Report

Start Date:2016-05-18 End Date:2016-05-19
Study :EMR700623-541Investigator :NACountry of Investigator :KoreaSiteNo:K01
Subject No :k01-0059Subject Initials :LKHDOB :08/05/1981Sex:FemaleRace:AsianHeight:153cmWeight:74g
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment06/02/2015225
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/13/201507/02/2015RelatedMild
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Dose not changedNoneResolved
Event Description:
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:No
ConditionStart DateRelated to study conditionOngoing



18-MAY-16
NA/EMR700623-541/k01-0059
Page 1 of26
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-05-18 End Date:2016-05-19
Study :EMR700623-541Investigator :NACountry of Investigator :KoreaSiteNo:K01
Subject No :k01-036Subject Initials :JSYDOB :07/28/1981Sex:FemaleRace:AsianHeight:162cmWeight:54g
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment03/13/2015225
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS03/24/201504/07/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Dose not changedNoneResolved
Event Description:
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:No
ConditionStart DateRelated to study conditionOngoing



18-MAY-16
NA/EMR700623-541/k01-036
Page 2 of26
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-05-18 End Date:2016-05-19
Study :EMR700623-541Investigator :NACountry of Investigator :KoreaSiteNo:K01
Subject No :k01-040Subject Initials :LBHDOB :03/05/1985Sex:FemaleRace:AsianHeight:164cmWeight:61g
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment04/06/2015225
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS04/15/201504/30/2015RelatedMild
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Dose not changedNoneResolved
Event Description:
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:No
ConditionStart DateRelated to study conditionOngoing



18-MAY-16
NA/EMR700623-541/k01-040
Page 3 of26
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-05-18 End Date:2016-05-19
Study :EMR700623-541Investigator :NACountry of Investigator :KoreaSiteNo:K01
Subject No :k01-050Subject Initials :KHGDOB :04/22/1984Sex:FemaleRace:AsianHeight:150cmWeight:46g
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/03/2015300
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS05/14/201505/29/2015RelatedMild
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Dose not changedLed 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
ovary cystectomyUK-Jan-2014Not on treatment/medication



18-MAY-16
NA/EMR700623-541/k01-050
Page 4 of26