Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0095Subject Initials :MLGDOB :08/19/1990Sex:FemaleRace:AsianHeight:155cmWeight:54.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/19/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS 05/31/201506/05/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:No
ConditionStart DateRelated to study conditionOngoing



26-APR-16
NA/EMR700623-541/C02-0095
Page 1 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0102Subject Initials :HYDDOB :10/14/1985Sex:FemaleRace:AsianHeight:163cmWeight:57.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/19/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS 06/01/201506/12/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:Moderate OHSS 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
Palace laparoscopy Uk-Unk-2013Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0102
Page 2 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0103Subject Initials :CPZDOB :05/12/1989Sex:FemaleRace:AsianHeight:165cmWeight:63.5kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/19/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS 06/02/201506/12/2015RelatedModerate
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
The right side of the open line on the right side of salpingectomy tubal pregnancy Uk-Unk-2011Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0103
Page 3 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0111Subject Initials :CXWDOB :10/10/1979Sex:FemaleRace:AsianHeight:162cmWeight:68.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/20/2015200
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/02/201506/12/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:Moderate OHSS 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
Ectopic pregnancy laparoscopic surgery, the left fallopian tube embryo window.Uk-Unk-2012Not on treatment/medication
Tubal lipiodol angiographyUk-Unk-2013Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0111
Page 4 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0115Subject Initials :KJTDOB :07/02/1988Sex:FemaleRace:AsianHeight:163cmWeight:52.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/21/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/06/201506/12/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:Moderate OHSS 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 examination: bilateral tubal occlusionUk-Unk-2012Not on treatment/medication
Laparoscopy surgery: pelvic sticky points, bilateral tubal ostomy + right side mesosalpinx cyst removal.Uk-May-2015Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0115
Page 5 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0118Subject Initials :MLFDOB :08/03/1984Sex:FemaleRace:AsianHeight:160cmWeight:55.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/21/2015150
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 Uk-Unk-2007Not on treatment/medication
Laparoscopic pelvic sticky points, bilateral ovarian drillingUk-Unk-2007Not on treatment/medication
Cervical biopsy showing inflammationUk-Unk-2015Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0118
Page 6 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0124Subject Initials :Y-CDOB :07/17/1982Sex:FemaleRace:AsianHeight:150cmWeight:48.5kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/21/2015225
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 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 left fallopian tube obstruction and hydrocephalus right salpingitisUk-Unk-2013Not on treatment/medication
Hysteroscopy normalUk-Mar-2015Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0124
Page 7 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0126Subject Initials :RCMDOB :01/09/1989Sex:FemaleRace:AsianHeight:165cmWeight:60.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/21/2015150
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 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 obstruction, poor uterine shape Uk-Unk-2013Not on treatment/medication
Hysteroscopy: uterine spindle-shaped, single horn.Uk-Unk-2014Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0126
Page 8 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0134Subject Initials :QYLDOB :06/17/1986Sex:FemaleRace:AsianHeight:155cmWeight:47.0kg
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
OHSS06/06/201506/12/2015RelatedModerate
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
Laparotomy: pelvic abscess incision and drainage, the right accessories cystectomyUk-Unk-2009Not on treatment/medication
Hysteroscopy normal uterine shapeUk-Unk-2013Not on treatment/medication
Hysteroscopic curettageUk-Unk-2015Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0134
Page 9 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0136Subject Initials :Q-LDOB :03/28/1984Sex:FemaleRace:AsianHeight:154cmWeight:47.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/22/2015200
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/08/201506/12/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:Moderate OHSS 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: bilateral tubal obstruction incompleteUk-Unk-2014Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0136
Page 10 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0137Subject Initials :YLFDOB :11/01/1989Sex:FemaleRace:AsianHeight:153cmWeight:47.0kg
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
OHSS06/09/201506/16/2015RelatedModerate
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 obstructionUk-Unk-2014Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0137
Page 11 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0138Subject Initials :TTJDOB :06/20/1990Sex:FemaleRace:AsianHeight:150cmWeight:41.0kg
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
OHSS06/06/201506/12/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:Moderate OHSS 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
Ectopic pregnancy laparoscopic surgery: the right fallopian tube embryo pelvic sticking pointsUk-Jan-2014Not on treatment/medication
Hysteroscopy: endometrial polyps.Uk-Feb-2015Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0138
Page 12 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
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
Other(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
 



26-APR-16
NA/EMR700623-541/C02-0142
Page 13 of 41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0143Subject Initials :F-LDOB :11/06/1982Sex:FemaleRace:AsianHeight:155cmWeight:51.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/22/2015225
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/08/201506/14/2015RelatedModerate
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 left fallopian tube obstruction, incomplete right fallopian tube obstructionUk-Unk-2012Not on treatment/medication
Laparoscopy surgery: pelvic stars stick + tubal surgery, endometriosis lesions fulgurationUk-Unk-2012Not on treatment/medication
 



26-APR-16
NA/EMR700623-541/C02-0143
Page 14 of 41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0153Subject Initials :H-HDOB :07/12/1979Sex:FemaleRace:AsianHeight:153cmWeight:43.5kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/25/2015250
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/10/201506/16/2015RelatedModerate
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
 



26-APR-16
NA/EMR700623-541/C02-0153
Page 15 of 41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0157Subject Initials :Y-ZDOB :07/22/1984Sex:FemaleRace:AsianHeight:156cmWeight:55.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/25/2015200
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/10/201506/16/2015RelatedModerate
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 obstructionUk-Unk-2010Not on treatment/medication
Laparoscopic Surgery: Tubal clear.Uk-Unk-2007Not on treatment/medication
Ectopic pregnancy laparoscopic surgery: tubal embryo window.Uk-Jan-2014Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0157
Page 16 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0161Subject Initials :H-YDOB :12/12/1985Sex:FemaleRace:AsianHeight:166cmWeight:57.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/26/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/10/201506/16/2015RelatedModerate
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: bilateral tubal obstruction Uk-Unk-2007Not on treatment/medication
Laparoscopic tubal surgery sticking points. Uk-Unk-2007Not on treatment/medication
Open left fallopian tube ectopic pregnancy surgeryUk-Unk-2012Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0161
Page 17 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0164Subject Initials :AHCDOB :12/12/1982Sex:FemaleRace:AsianHeight:156cmWeight:49.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/26/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/12/201506/20/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:Moderate OHSS 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 side Uk-Unk-2012Not on treatment/medication
Laparoscopy Surgery: salpingostomy, pelvic adhesions dissection.Uk-Unk-2012Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0164
Page 18 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0169Subject Initials :L-WDOB :06/08/1985Sex:FemaleRace:AsianHeight:166cmWeight:50.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/27/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/12/201506/20/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableNoneResolved
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 insufficiencyUk-Jun-2014Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0169
Page 19 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0174Subject Initials :YXCDOB :06/04/2015Sex:FemaleRace:AsianHeight:155cmWeight:54.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/27/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/12/201506/16/2015RelatedModerate
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
Laparoscopic surgery: left ovarian endometriosis cystectomyUk-Unk-2010Not on treatment/medication
HSG: the left fallopian tube obstruction, right fallopian tube inflammation.Uk-Unk-2012Not on treatment/medication
Laparoscopic surgery: pelvic adhesions dissection, left fallopian tube plastic surgeryUk-Unk-2012Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0174
Page 20 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0175Subject Initials :L-TDOB :02/15/1989Sex:FemaleRace:AsianHeight:158cmWeight:40.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/27/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/11/201506/16/2015RelatedModerate
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: bilateral tubal obstruction. Uk-Aug-2014Not on treatment/medication
Laparoscopy surgery: pelvic adhesions dissection, tubal plastic surgery to repair the left corpus luteum cyst cystectomy,Uk-Unk-2014Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0175
Page 21 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0176Subject Initials :KBFDOB :05/19/1986Sex:FemaleRace:AsianHeight:160cmWeight:57.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/27/2015200
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/11/201506/16/2015RelatedModerate
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
Tubal examination: passableUk-Unk-2008Not on treatment/medication
HSG: bilateral tubal occlusionUk-Unk-2009Not on treatment/medication
Laparoscopy surgery: bilateral tubal repair plastic surgery, pelvic adhesions dissectionUk-Unk-2011Not on treatment/medication
Ectopic pregnancy: open surgeryUk-Unk-2012Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0176
Page 22 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0178Subject Initials :XSCDOB :10/11/1988Sex:FemaleRace:AsianHeight:155cmWeight:54.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/27/2015200
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/10/201506/16/2015RelatedModerate
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: bilateral tubal resistance. Uk-Jan-2013Not on treatment/medication
Laparoscopy surgery: pelvic adhesions dissection, bilateral salpingo-repair plastic surgery, normal uterine shape.Uk-Jan-2013Not on treatment/medication
Hysteroscopy normal, water surgery: incomplete right fallopian tube obstructionUk-Feb-2015Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0178
Page 23 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0179Subject Initials :HYZDOB :05/14/1991Sex:FemaleRace:AsianHeight:158cmWeight:53.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/27/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/11/201506/16/2015RelatedModerate
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
Ectopic pregnancy laparotomy: the left fallopian tube removal.Uk-Unk-2009Not on treatment/medication
Abdominal ectopic pregnancy conservative surgery.Uk-Unk-2010Not on treatment/medication
Hysteroscopy: endometrial polyp excision.Uk-Jan-2015Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0179
Page 24 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0180Subject Initials :YPWDOB :08/20/1982Sex:FemaleRace:AsianHeight:156cmWeight:57.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/27/2015225
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/13/201506/16/2015RelatedModerate
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
Ectopic pregnancy: treatment of chemical drugs to kill embryosUk-Unk-2012Not on treatment/medication
HSG: bilateral tubal occlusionUk-Unk-2008Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0180
Page 25 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0185Subject Initials :YMXDOB :09/07/1975Sex:FemaleRace:AsianHeight:159cmWeight:63.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/28/2015225
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/15/201506/20/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:Moderate OHSS 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-2013Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0185
Page 26 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0190Subject Initials :F-HDOB :03/09/1984Sex:FemaleRace:AsianHeight:160cmWeight:55.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/28/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/12/201506/16/2015RelatedModerate
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



26-APR-16
NA/EMR700623-541/C02-0190
Page 27 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0191Subject Initials :SYZDOB :02/16/1983Sex:FemaleRace:AsianHeight:162cmWeight:58.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/28/2015200
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/14/201506/18/2015RelatedModerate
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 with effusionUk-Unk-2008Not on treatment/medication
Tubal treatment: Tips patencyUk-Unk-2008Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0191
Page 28 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0195Subject Initials :J-LDOB :08/15/1984Sex:FemaleRace:AsianHeight:156cmWeight:48.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/28/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/14/201506/18/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:Moderate OHSS 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: bilateral tubal patency, pelvic adhesions.Uk-Unk-2012Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0195
Page 29 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0200Subject Initials :L-ZDOB :12/17/1988Sex:FemaleRace:AsianHeight:155cmWeight:70.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/28/2015187.5
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/13/201506/18/2015RelatedModerate
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 obstruction Uk-Apr-2014Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0200
Page 30 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0202Subject Initials :F-QDOB :06/09/1985Sex:FemaleRace:AsianHeight:159cmWeight:65.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment08/27/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS09/11/201509/16/2015RelatedModerate
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: bilateral tubal patencyUk-Unk-2013Not on treatment/medication
Laparoscopic surgery: pelvic adhesions dissection, bilateral mesosalpinx cystectomyUk-Unk-2014Not on treatment/medication
Tubal examination: smoothUk-Unk-2014Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0202
Page 31 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0206Subject Initials :YPZDOB :10/20/1980Sex:FemaleRace:AsianHeight:150cmWeight:47.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment08/28/2015187.5
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-2011Not on treatment/medication
Laparoscopy surgery: pelvic adhesions dissection, bilateral tubal surgery to clear.Uk-Unk-2011Not on treatment/medication
HSG: bilateral tubal occlusion Uk-Unk-2013Not on treatment/medication
Laparoscopy surgery: pelvic adhesions dissection, uterine fibroids dug surgery, tubal surgery to clear, coherent liquid skill.Uk-Unk-2013Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0206
Page 32 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0207Subject Initials :JHZDOB :09/03/2015Sex:FemaleRace:AsianHeight:160cmWeight:55.0kg
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
OHSS09/13/201509/18/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:Moderate OHSS 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
Ectopic pregnancy laparoscopic surgery: Left salpingectomyUk-Unk-2011Not on treatment/medication
Ectopic pregnancy laparoscopic surgery: Right salpingectomyUk-Unk-2013Not on treatment/medication
HSG: bilateral tubal occlusion Uk-Unk-2014Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0207
Page 33 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-04-26 End Date:2016-04-27
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0208Subject Initials :MQWDOB :09/24/1988Sex:FemaleRace:AsianHeight:156cmWeight:54.0kg
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
Hysteroscopic resection of endometrial polypsUk-Unk-2015Not on treatment/medication



26-APR-16
NA/EMR700623-541/C02-0208
Page 34 of41