Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :Fei GongCountry of Investigator :ChinaSiteNo:C01
Subject No :C01-0001Subject Initials :TTWDOB :05/13/1988Sex:FemaleRace:AsianHeight:157cmWeight:3050g
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/16/2015112.5
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/06/201506/15/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableConcomitant procedure**Resolved
Event Description:Nausea, vomiting, yellow urine with less volume, chest pelvic effusion,ascites puncture 10-Jun-2015,2200ml;ascites puncture 15-Jun-2015,2900ml;
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
ConditionStart DateRelated to study conditionOngoing
Bilateral fallopian tube obstruction04/11/2014Not on treatment/medicationOngoing



18-AUG-16
Fei Gong/EMR700623-541/C01-0001
Page 1 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :Fei GongCountry of Investigator :ChinaSiteNo:C01
Subject No :C01-0068Subject Initials :X-SDOB :04/16/1989Sex:FemaleRace:AsianHeight:160cmWeight:2500g
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment06/27/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS07/23/201508/04/2015RelatedSevere
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 23Jul2015,1000ml; 27Jul2015,2100ml; 30Jul2015,2500ml; 04Aug2015,2000ml;
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
ConditionStart DateRelated to study conditionOngoing
The left Hydrosalpinx and adhesions,less patency.Right fallopian tube partially blocked03/22/2014Not on treatment/medicationOngoing
right fallopian tube resection because of Ectopic pregnancyUK-Oct-2011Not on treatment/medication



18-AUG-16
Fei Gong/EMR700623-541/C01-0068
Page 2 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
Fei Gong/EMR700623-541/C01-0158
Page 3 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0002Subject Initials :LLLDOB :02/12/1987Sex:FemaleRace:AsianHeight:158cmWeight:50.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/08/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS05/25/201506/03/2015RelatedModerate
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
salpingemphrxis,lalace peritoneoscopeUk-Jul-2014Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0002
Page 4 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0008Subject Initials :R-HDOB :02/06/1993Sex:FemaleRace:AsianHeight:158cmWeight:51.0kg
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
OHSS05/27/201506/05/2015RelatedModerate
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
laparoscope hydrotubationUk-Unk-2013Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0008
Page 5 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0010
Page 6 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0011Subject Initials :P-XDOB :12/07/1994Sex:FemaleRace:AsianHeight:160cmWeight:60.0kg
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
OHSS05/27/201506/03/2015RelatedModerate
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 Salping ectomyUk-Unk-2013On treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0011
Page 7 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0023Subject Initials :JYFDOB :11/10/1981Sex:FemaleRace:AsianHeight:163cmWeight:70.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/12/2015300
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS05/30/201506/05/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:Moderate OHSS 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
Hysteroscopy Salpingemphraxis Uk-Mar-2015Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0023
Page 8 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0024Subject Initials :HXGDOB :10/06/1992Sex:FemaleRace:AsianHeight:150cmWeight:55.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/12/2015200
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:No
ConditionStart DateRelated to study conditionOngoing



18-AUG-16
NA/EMR700623-541/C02-0024
Page 9 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0026Subject Initials :HCJDOB :07/07/1993Sex:FemaleRace:AsianHeight:161cmWeight:53.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/12/2015200
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS05/30/201506/05/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:Moderate OHSS 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 with left tubal ectopic pregnancy resectionUk-Unk-2011Not on treatment/medication
Under ectopic pregnancy laparoscopic conservative surgeryUk-Unk-2012Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0026
Page 10 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0028Subject Initials :XHLDOB :04/12/1981Sex:FemaleRace:AsianHeight:158cmWeight:65.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/12/2015225
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS 05/28/201506/03/2015RelatedModerate
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
Left abdominal ectopic pregnancy salpingectomyUk-Unk-2002Not on treatment/medication
Right next laparoscopic tubal ectopic pregnancy surgeryUk-Unk-2010Not on treatment/medication
Conservative treatment of ectopic pregnancyUk-Unk-2004Not on treatment/medication
Conservative treatment of ectopic pregnancyUk-Unk-2005Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0028
Page 11 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0029Subject Initials :XLXDOB :06/08/1981Sex:FemaleRace:AsianHeight:158cmWeight:70.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/12/2015250
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/01/201506/07/2015RelatedModerate
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
Pelvic mass laparoscopic pelvic surgery sticky points, bilateral tubal ostomy, left ovarian drilling, tubal.Uk-Unk-2013Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0029
Page 12 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0034Subject Initials :L-ZDOB :09/04/1981Sex:FemaleRace:AsianHeight:156cmWeight:53.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/13/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS05/30/201506/05/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:Moderate OHSS 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



18-AUG-16
NA/EMR700623-541/C02-0034
Page 13 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0043Subject Initials :F-HDOB :03/13/1983Sex:FemaleRace:AsianHeight:164cmWeight:54.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/13/2015225
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS05/30/201506/05/2015RelatedModerate
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
Laparoscopic tubal ectopic pregnancy at the right side of the window to take embryoUk-Unk-2005Not on treatment/medication
Under the right fallopian tube ectopic pregnancy laparoscopic surgeryUk-Unk-2007Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0043
Page 14 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0045Subject Initials :H-TDOB :09/08/1983Sex:FemaleRace:AsianHeight:158cmWeight:57.5kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/13/2015250
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:Yes
ConditionStart DateRelated to study conditionOngoing
Hysteroscopic polypectomyUk-Aug-2014Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0045
Page 15 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0046Subject Initials :Q-HDOB :10/07/1985Sex:FemaleRace:AsianHeight:161cmWeight:50.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/13/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS05/28/201506/05/2015RelatedModerate
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:No
ConditionStart DateRelated to study conditionOngoing



18-AUG-16
NA/EMR700623-541/C02-0046
Page 16 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0049Subject Initials :HPTDOB :09/16/1980Sex:FemaleRace:AsianHeight:155cmWeight:50.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/14/2015187.5
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS05/31/201506/03/2015RelatedModerate
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
Laparoscopic surgery appendicitisUk-Unk-2012Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0049
Page 17 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0051Subject Initials :YQXDOB :01/15/1983Sex:FemaleRace:AsianHeight:154cmWeight:50.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/14/2015225
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:Yes
ConditionStart DateRelated to study conditionOngoing
salpingemphraxis,laparoscopic operationUk-Unk-2012Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0051
Page 18 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0052Subject Initials :YLLDOB :02/07/1992Sex:FemaleRace:AsianHeight:165cmWeight:54.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/14/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS05/30/201506/05/2015RelatedModerate
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:No
ConditionStart DateRelated to study conditionOngoing



18-AUG-16
NA/EMR700623-541/C02-0052
Page 19 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0053Subject Initials :YNDDOB :04/13/1992Sex:FemaleRace:AsianHeight:155cmWeight:45.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/14/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS05/30/201506/05/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:Moderate OHSS 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 tubal colostomy, pelvic surgery sticky points.Uk-Unk-2013Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0053
Page 20 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0059Subject Initials :J-LDOB :12/23/1984Sex:FemaleRace:AsianHeight:155cmWeight:50.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/14/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS05/31/201506/05/2015RelatedModerate
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



18-AUG-16
NA/EMR700623-541/C02-0059
Page 21 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0060Subject Initials :Y-WDOB :11/10/1981Sex:FemaleRace:AsianHeight:150cmWeight:45.5kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/14/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS 05/30/201506/03/2015RelatedModerate
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
Laparoscopic pelvic sticking points, ovarian drilling, tubal surgery to clear.Uk-Unk-2014Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0060
Page 22 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0061Subject Initials :T-DDOB :02/15/1988Sex:FemaleRace:AsianHeight:161cmWeight:60.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/14/2015150
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:Yes
ConditionStart DateRelated to study conditionOngoing
salpingemphraxis,laparoscopic operationUk-Unk-2014Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0061
Page 23 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0062Subject Initials :FQRDOB :07/25/1983Sex:FemaleRace:AsianHeight:162cmWeight:46.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/14/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS05/30/201506/03/2015RelatedModerate
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
Hysteroscopic tubal inspectionUk-May-2014Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0062
Page 24 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0063Subject Initials :HMCDOB :07/25/1981Sex:FemaleRace:AsianHeight:162cmWeight:50.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/15/2015250
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS 06/01/201506/05/2015RelatedModerate
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:Yes
ConditionStart DateRelated to study conditionOngoing
Hysteroscopic surgery through liquidUk-Unk-2014Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0063
Page 25 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0070Subject Initials :ZQCDOB :02/08/1977Sex:FemaleRace:AsianHeight:164cmWeight:67.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/15/2015200
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS 05/28/201506/03/2015RelatedModerate
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



18-AUG-16
NA/EMR700623-541/C02-0070
Page 26 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0071Subject Initials :LLXDOB :07/13/1987Sex:FemaleRace:AsianHeight:157cmWeight:41.5kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/15/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS05/31/201506/05/2015RelatedModerate
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:Yes
ConditionStart DateRelated to study conditionOngoing
Laparoscopic pelvic sub sticky, sticky points left fallopian tube surgery.Uk-Unk-2014Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0071
Page 27 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0076Subject Initials :F-LDOB :05/15/1987Sex:FemaleRace:AsianHeight:150cmWeight:51.5kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/15/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS 05/30/201506/03/2015RelatedModerate
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
Sticky points lower pelvic laparoscopy surgery, tubal surgery.Uk-Unk-2012Not on treatment/medication
Hysteroscopic tubal surgeryUk-Sep-2014Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0076
Page 28 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0082Subject Initials :Y-LDOB :09/04/1986Sex:FemaleRace:AsianHeight:162cmWeight:59.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/18/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS 06/02/201506/05/2015RelatedModerate
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



18-AUG-16
NA/EMR700623-541/C02-0082
Page 29 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0083Subject Initials :Y-LDOB :08/20/1988Sex:FemaleRace:AsianHeight:158cmWeight:54.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/18/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS 06/03/201506/05/2015RelatedModerate
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
Laparoscopic pelvic sticky points left salpingostomyUk-Unk-2013Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0083
Page 30 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0086Subject Initials :YZZDOB :07/07/1987Sex:FemaleRace:AsianHeight:150cmWeight:55.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/18/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS 06/04/201506/12/2015RelatedModerate
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:No
ConditionStart DateRelated to study conditionOngoing



18-AUG-16
NA/EMR700623-541/C02-0086
Page 31 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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 06/02/201506/05/2015RelatedModerate
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



18-AUG-16
NA/EMR700623-541/C02-0087
Page 32 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0088Subject Initials :HLKDOB :06/14/1986Sex:FemaleRace:AsianHeight:159cmWeight:59.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/18/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS 06/02/201506/05/2015RelatedModerate
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:Yes
ConditionStart DateRelated to study conditionOngoing
Palace laparoscopic pelvic surgery sticky points, bilateral tubal plastic surgery, endometriosis lesions fulguration.Uk-Unk-2012Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0088
Page 33 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0089Subject Initials :XYZDOB :06/12/1986Sex:FemaleRace:AsianHeight:152cmWeight:48.5kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/18/2015187.5
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS 06/07/201506/12/2015RelatedModerate
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
Sticky points pelvic laparoscopy surgery, tubal surgery to clearUk-Nov-2012Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0089
Page 34 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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 06/03/201506/05/2015RelatedModerate
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



18-AUG-16
NA/EMR700623-541/C02-0095
Page 35 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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 06/04/201506/12/2015RelatedModerate
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



18-AUG-16
NA/EMR700623-541/C02-0102
Page 36 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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 06/05/201506/12/2015RelatedModerate
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
The right side of the open line on the right side of salpingectomy tubal pregnancy Uk-Unk-2011Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0103
Page 37 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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
OHSS06/05/201506/12/2015RelatedModerate
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



18-AUG-16
NA/EMR700623-541/C02-0111
Page 38 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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
OHSS06/05/201506/12/2015RelatedModerate
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



18-AUG-16
NA/EMR700623-541/C02-0115
Page 39 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0118
Page 40 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0124
Page 41 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0126
Page 42 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0134
Page 43 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0136
Page 44 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0137
Page 45 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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 applicableNoneResolved
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



18-AUG-16
NA/EMR700623-541/C02-0138
Page 46 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0142
Page 47 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0143
Page 48 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0153
Page 49 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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-2006Not 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



18-AUG-16
NA/EMR700623-541/C02-0157
Page 50 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0161
Page 51 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0164
Page 52 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0169
Page 53 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0174Subject Initials :YXCDOB :06/04/1982Sex: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



18-AUG-16
NA/EMR700623-541/C02-0174
Page 54 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0175
Page 55 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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
OHSS06/11/201506/17/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableNoneResolved
Event Description:OHSS occurs not put embryos
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



18-AUG-16
NA/EMR700623-541/C02-0176
Page 56 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0178
Page 57 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0179
Page 58 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0180
Page 59 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0185
Page 60 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0190
Page 61 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0191
Page 62 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0195
Page 63 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0200
Page 64 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0201Subject Initials :J-LDOB :12/15/1990Sex:FemaleRace:AsianHeight:168cmWeight:65kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment09/07/2015225
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS09/26/201510/02/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:Moderate OHSS 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 occlusionUk-Unk-2012Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0201
Page 65 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0202
Page 66 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0206
Page 67 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0207Subject Initials :JHZDOB :09/03/1984Sex: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



18-AUG-16
NA/EMR700623-541/C02-0207
Page 68 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0208
Page 69 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0210
Page 70 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0215
Page 71 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0217Subject Initials :YQXDOB :02/10/1987Sex:FemaleRace:AsianHeight:157cmWeight:60.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment08/31/2015187.5
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 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 therapy chemotherapy to kill embryos Uk-Unk-2011Not on treatment/medication
HSG: bilateral tubal obstruction.Uk-Unk-2010Not on treatment/medication
Laparoscopy surgery: pelvic adhesions dissection, bilateral tubal surgery to clearUk-Unk-2010Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0217
Page 72 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0219Subject Initials :YLZDOB :06/17/1986Sex:FemaleRace:AsianHeight:160cmWeight:46.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment08/31/2015150
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 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-2011Not on treatment/medication
HSG: bilateral tubal patency, pelvic adhesions. Uk-Unk-2014Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0219
Page 73 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0220Subject Initials :CCTDOB :05/15/1985Sex:FemaleRace:AsianHeight:152cmWeight:51.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment08/31/2015150
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: bilateral tubal patency. Uk-Unk-2014Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0220
Page 74 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0222Subject Initials :YMDDOB :04/19/1983Sex:FemaleRace:AsianHeight:158cmWeight:42.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment08/31/2015225
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS09/16/201509/20/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event Description:Moderate OHSS 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: the side of tubal passable. Uk-Unk-2012Not on treatment/medication
Laparoscopic surgery: bilateral tubal surgery, right fallopian tube patency.Uk-Unk-2012Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0222
Page 75 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0224Subject Initials :JXLDOB :11/11/1985Sex:FemaleRace:AsianHeight:158cmWeight:52.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment09/01/2015225
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS09/19/201509/25/2015RelatedModerate
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 occlusion in the left effusionUk-Unk-2014Not on treatment/medication
Laparoscopic pelvic adhesions dissection and bilateral tubal fluid plastic ostomy, hysteroscopic resection of endometrial polyps palaceUk-Unk-2014Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0224
Page 76 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0226Subject Initials :BQXDOB :07/10/1987Sex:FemaleRace:AsianHeight:160cmWeight:53.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment09/01/2015187.5
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS09/17/201509/22/2015RelatedModerate
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 classification pelvic adhesions, tubal fluid prostheticsUk-Unk-2010Not on treatment/medication
Laparoscopic surgery classification pelvic adhesions, tubal fluid prostheticsUk-Unk-2011Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0226
Page 77 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0227Subject Initials :YXZDOB :12/09/1985Sex:FemaleRace:AsianHeight:164cmWeight:56.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment09/01/2015187.5
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS09/17/201509/22/2015RelatedModerate
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
Abdominal ectopic pregnancy conservative surgery.Uk-Unk-2012Not on treatment/medication
Ectopic pregnancy laparoscopic conservative surgery.Uk-Unk-2013Not on treatment/medication
HSG: incomplete right fallopian tube obstruction, left fallopian tube fluid. Uk-Unk-2014Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0227
Page 78 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0228Subject Initials :J-XDOB :09/12/1981Sex:FemaleRace:AsianHeight:160cmWeight:51.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment09/02/2015225
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS09/20/201509/25/2015RelatedModerate
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: right fallopian tube obstruction. Uk-Unk-2013Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0228
Page 79 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0229Subject Initials :HYTDOB :11/13/1992Sex:FemaleRace:AsianHeight:153cmWeight:45.5kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment09/02/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS09/18/201509/24/2015RelatedModerate
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 occlusion Uk-Unk-2013Not on treatment/medication
Laparoscopic surgery: pelvic adhesions dissection, tubal plasty, uterine fibroids dug surgery, uterine suspension surgery.Uk-Unk-2013Not on treatment/medication
Hysteroscopy normalUk-Unk-2015Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0229
Page 80 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0230Subject Initials :F-XDOB :07/08/1987Sex:FemaleRace:AsianHeight:156cmWeight:51.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment09/02/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS09/18/201509/24/2015RelatedModerate
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
Caesarean sectionUk-Unk-2009Not on treatment/medication
HSG: bilateral tubal occlusion Uk-Mar-2015Not on treatment/medication
Hysteroscopy normal Uk-Unk-2015Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0230
Page 81 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0231Subject Initials :LJSDOB :08/28/1981Sex:FemaleRace:AsianHeight:160cmWeight:69.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment09/02/2015300
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS09/17/201509/24/2015RelatedModerate
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 passableUk-Unk-2013Not on treatment/medication
Palace laparoscopyUk-Unk-2014Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0231
Page 82 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0239Subject Initials :JJLDOB :01/25/1984Sex:FemaleRace:AsianHeight:158cmWeight:49.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment09/06/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS09/23/201509/27/2015RelatedModerate
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: incomplete right fallopian tube obstruction, left fallopian tube obstruction Uk-Mar-2015Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0239
Page 83 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0240Subject Initials :DMXDOB :01/01/1985Sex:FemaleRace:AsianHeight:155cmWeight:47.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment09/06/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS09/21/201509/26/2015RelatedModerate
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
Laparoscopy surgery: pelvic adhesions separation surgery, plastic surgery to repair the fallopian tubes, uterine cavity is normal.Uk-Unk-2013Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0240
Page 84 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0244Subject Initials :DDWDOB :09/13/1986Sex:FemaleRace:AsianHeight:160cmWeight:53.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment09/06/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS09/22/201509/27/2015RelatedModerate
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 patencyUk-Unk-2008Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0244
Page 85 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0247Subject Initials :BSHDOB :08/12/1987Sex:FemaleRace:AsianHeight:155cmWeight:40.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment09/07/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS09/23/201509/27/2015RelatedModerate
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, incomplete left fallopian tube obstruction Uk-Mar-2014Not on treatment/medication
Laparoscopy surgery: dissection of pelvic adhesions, tubal repair plastic surgery, and it was surgery.Uk-Apr-2014Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C02-0247
Page 86 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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



18-AUG-16
NA/EMR700623-541/C02-0249
Page 87 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C04
Subject No :C04-0087Subject Initials :HZDDOB :08/04/1983Sex:FemaleRace:AsianHeight:161cmWeight:60kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment06/26/2015225
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS07/07/201507/21/2015RelatedMild
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Dose reducedNoneResolved
Event Description:none
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
ConditionStart DateRelated to study conditionOngoing
spontaneous abortion01/05/2010Not on treatment/medication
spontaneous abortion05/18/2012Not on treatment/medication



18-AUG-16
NA/EMR700623-541/C04-0087
Page 88 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C04
Subject No :C04-0171Subject Initials :SHLDOB :08/17/1987Sex:FemaleRace:AsianHeight:154cmWeight:40kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment09/29/2015300
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS09/30/201510/09/2015RelatedMild
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Dose reducedNoneResolved
Event Description:none
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:No
ConditionStart DateRelated to study conditionOngoing



18-AUG-16
NA/EMR700623-541/C04-0171
Page 89 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :Ying ZhongCountry of Investigator :ChinaSiteNo:C05
Subject No :C05-0001Subject Initials :XFZDOB :01/21/1988Sex:FemaleRace:AsianHeight:159cmWeight:50kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment08/01/2015225
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS08/16/201508/18/2015RelatedSevere
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableNoneResolved
Event Description: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
oophorocystectomyUK-Jul-2013Not on treatment/medication
salpingoplastyUK-Feb-2014Not on treatment/medication
salpingitis after previous tubal occlusionUK-Feb-2014Not on treatment/medicationOngoing



18-AUG-16
Ying Zhong/EMR700623-541/C05-0001
Page 90 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :Ying ZhongCountry of Investigator :ChinaSiteNo:C05
Subject No :C05-0010Subject Initials :Q-ZDOB :01/31/1990Sex:FemaleRace:AsianHeight:159cmWeight:45kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment08/02/2015225
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS08/17/201508/24/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
Disease under study**,Protocol procedure**,Concomitant medication**(Othervalue:)Dose not changedLed to study terminationResolved
Event Description:abdominal distention;nausea Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 17-Aug-2015 / 27-Aug-2015
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:No
ConditionStart DateRelated to study conditionOngoing



18-AUG-16
Ying Zhong/EMR700623-541/C05-0010
Page 91 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :Ying ZhongCountry of Investigator :ChinaSiteNo:C05
Subject No :C05-0013Subject Initials :L-LDOB :06/12/1986Sex:FemaleRace:AsianHeight:159cmWeight:54.5kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment08/02/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS08/18/201508/20/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
Disease under study**,Protocol procedure**,Concomitant medication**(Othervalue:)Dose not changedLed to study terminationResolved
Event Description:abdominal distention;nausea ,ascites,Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 18-Aug-2015 / 20-Aug-2015
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
ConditionStart DateRelated to study conditionOngoing
ampullary pregnancyUK-Unk-2010Not on treatment/medication
ampullary pregnancyUK-Unk-2012Not on treatment/medication
ampullary pregnancyUK-Unk-2013Not on treatment/medication
salpingocatheterismUK-Unk-2013Not on treatment/medication



18-AUG-16
Ying Zhong/EMR700623-541/C05-0013
Page 92 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :Ying ZhongCountry of Investigator :ChinaSiteNo:C05
Subject No :C05-0021Subject Initials :FYZDOB :08/28/1990Sex:FemaleRace:AsianHeight:150cmWeight:45kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment08/04/2015225
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS08/19/201508/21/2015RelatedMild
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
Protocol procedure**,Concomitant medication**(Othervalue:)Not applicableNoneResolved
Event Description:abdominal distention;Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 19-Aug-2015 / 21-Aug-2015
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
ConditionStart DateRelated to study conditionOngoing
salpingocatheterismUK-Unk-2012Not on treatment/medication



18-AUG-16
Ying Zhong/EMR700623-541/C05-0021
Page 93 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :Ying ZhongCountry of Investigator :ChinaSiteNo:C05
Subject No :C05-0041Subject Initials :W-YDOB :07/03/1981Sex:FemaleRace:AsianHeight:153cmWeight:55kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment08/08/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS08/23/201508/25/2015RelatedMild
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
Protocol procedure**,Concomitant medication**(Othervalue:)Dose not changedLed to study terminationResolved
Event Description:abdominal distention;Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 21-Aug-2015 / 25-Aug-2015
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:No
ConditionStart DateRelated to study conditionOngoing



18-AUG-16
Ying Zhong/EMR700623-541/C05-0041
Page 94 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :Ying ZhongCountry of Investigator :ChinaSiteNo:C05
Subject No :C05-0056Subject Initials :X-PDOB :06/14/1983Sex:FemaleRace:AsianHeight:158cmWeight:46kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment08/13/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS08/27/201508/29/2015RelatedMild
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
Protocol procedure**,Concomitant medication**(Othervalue:)Not applicableLed to study terminationResolved
Event Description:abdominal distention;nausea ;ascites;Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 17-Aug-2015 / 27-Aug-2015
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:No
ConditionStart DateRelated to study conditionOngoing



18-AUG-16
Ying Zhong/EMR700623-541/C05-0056
Page 95 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :Ying ZhongCountry of Investigator :ChinaSiteNo:C05
Subject No :C05-0068Subject Initials :YPLDOB :12/07/1985Sex:FemaleRace:AsianHeight:160cmWeight:50kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment08/15/2015225
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS08/27/201508/29/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
Protocol procedure**,Concomitant medication**(Othervalue:)Dose not changedLed to study terminationResolved
Event Description:abdominal distention;nausea ;ascites;Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 17-Aug-2015 / 27-Aug-2015
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-2010Not on treatment/medication



18-AUG-16
Ying Zhong/EMR700623-541/C05-0068
Page 96 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :Ying ZhongCountry of Investigator :ChinaSiteNo:C05
Subject No :C05-0117Subject Initials :Y-LDOB :04/16/1982Sex:FemaleRace:AsianHeight:165cmWeight:48kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment08/23/2015225
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS09/08/201509/10/2015RelatedMild
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
Protocol procedure**,Concomitant medication**(Othervalue:)Dose reducedLed to study terminationResolved
Event Description:abdominal distention;ascites;Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 19-Aug-2015 / 21-Aug-2015
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:No
ConditionStart DateRelated to study conditionOngoing



18-AUG-16
Ying Zhong/EMR700623-541/C05-0117
Page 97 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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:
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



18-AUG-16
Ying Zhong/EMR700623-541/C05-0132
Page 98 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :Ying ZhongCountry of Investigator :ChinaSiteNo:C05
Subject No :C05-0141Subject Initials :XHZDOB :04/14/1987Sex:FemaleRace:AsianHeight:158cmWeight:48kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment08/29/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS09/12/201509/14/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
Protocol procedure**,Concomitant medication**(Othervalue:)Dose not changedLed to study terminationResolved
Event Description:abdominal distention;nausea ;ascites;Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 17-Aug-2015 / 27-Aug-2015
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-2009Not on treatment/medication



18-AUG-16
Ying Zhong/EMR700623-541/C05-0141
Page 99 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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-AUG-16
NA/EMR700623-541/k01-0059
Page 100 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :KoreaSiteNo:K01
Subject No :k01-035Subject Initials :PSSDOB :01/19/1983Sex:FemaleRace:AsianHeight:161cmWeight:56g
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment03/11/2015225
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS03/23/201504/21/2015RelatedMild
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Dose not changedNoneResolved
Event Description: no addtional data
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:No
ConditionStart DateRelated to study conditionOngoing



18-AUG-16
NA/EMR700623-541/k01-035
Page 101 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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 changedConcomitant medication **Resolved
Event Description:
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:No
ConditionStart DateRelated to study conditionOngoing



18-AUG-16
NA/EMR700623-541/k01-036
Page 102 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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-AUG-16
NA/EMR700623-541/k01-040
Page 103 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
Study :EMR700623-541Investigator :NACountry of Investigator :KoreaSiteNo:K01
Subject No :k01-049Subject Initials :PGRDOB :02/20/1983Sex:FemaleRace:AsianHeight:168cmWeight:62g
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/02/2015300
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS05/13/201505/29/2015RelatedMild
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableConcomitant medication **Resolved
Event Description:albumin treatment and resloved
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
ConditionStart DateRelated to study conditionOngoing
laparoscopic ovary cystectomyUK-UNK-2004Not on treatment/medication



18-AUG-16
NA/EMR700623-541/k01-049
Page 104 of174
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-17 End Date:2016-08-18
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-AUG-16
NA/EMR700623-541/k01-050
Page 105 of174