Non Serious Adverse Drug Reactions Report

Start Date:2016-05-06 End Date:2016-05-09
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0010Subject Initials :Y-HDOB :10/18/1985Sex:FemaleRace:AsianHeight:153cmWeight:47.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/11/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS05/29/201506/02/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:Moderate OHSS patients, improved canceled after embryo transfer.
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:No
ConditionStart DateRelated to study conditionOngoing



09-MAY-16
NA/EMR700623-541/C02-0010
Page 1 of8
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-05-06 End Date:2016-05-09
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0087Subject Initials :XPTDOB :06/15/1988Sex:FemaleRace:AsianHeight:158cmWeight:57.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS 05/30/201506/05/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:Moderate OHSS patients, improved canceled after embryo transfer.
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
ConditionStart DateRelated to study conditionOngoing
Hysteroscopy normalUk-Mar-2015Not on treatment/medication



09-MAY-16
NA/EMR700623-541/C02-0087
Page 2 of8
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-05-06 End Date:2016-05-09
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0142Subject Initials :HMTDOB :02/19/1988Sex:FemaleRace:AsianHeight:168cmWeight:46.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/22/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/07/201506/12/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement
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 and hydrocephalusUk-Unk-2014Not on treatment/medication
Laparoscopy surgery: pelvic stars stick + fulguration of endometriosis foci, tubal plastic surgeryUk-Unk-2014Not on treatment/medication



09-MAY-16
NA/EMR700623-541/C02-0142
Page 3 of8
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-05-06 End Date:2016-05-09
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0210Subject Initials :GLWDOB :05/08/1983Sex:FemaleRace:AsianHeight:160cmWeight:55.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment08/28/2015225
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS09/15/201509/20/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:Moderate OHSS patients, improved canceled after embryo transfer.
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
ConditionStart DateRelated to study conditionOngoing
HSG: the right fallopian tube obstructionUk-Unk-2014Not on treatment/medication



09-MAY-16
NA/EMR700623-541/C02-0210
Page 4 of8
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-05-06 End Date:2016-05-09
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0215Subject Initials :L-XDOB :08/05/1989Sex:FemaleRace:AsianHeight:165cmWeight:56.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment08/28/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS09/14/201509/18/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
ConditionStart DateRelated to study conditionOngoing
HSG: bilateral tubal occlusion Uk-Unk-2014Not on treatment/medication
Under laparoscopy surgery to clear the fallopian tubes, pelvic adhesions dissectionUk-Unk-2014Not on treatment/medication



09-MAY-16
NA/EMR700623-541/C02-0215
Page 5 of8
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-05-06 End Date:2016-05-09
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0249Subject Initials :ZPYDOB :09/13/1982Sex:FemaleRace:AsianHeight:162cmWeight:55.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment09/07/2015187.5
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS09/22/201509/28/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event description:Moderate OHSS patients, improved canceled after embryo transfer.
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
ConditionStart DateRelated to study conditionOngoing
HSG: incomplete right fallopian tube obstruction, left fallopian tube obstructionUk-Unk-2015Not on treatment/medication
 



09-MAY-16
NA/EMR700623-541/C02-0249
Page 6 of 8