Non Serious Adverse Drug Reactions Report

Start Date:2016-08-19 End Date:2016-08-20
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



19-AUG-16
Fei Gong/EMR700623-541/C01-0001
Page 1 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-19 End Date:2016-08-20
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



19-AUG-16
Fei Gong/EMR700623-541/C01-0068
Page 2 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-19 End Date:2016-08-20
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



19-AUG-16
Fei Gong/EMR700623-541/C01-0158
Page 3 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-19 End Date:2016-08-20
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



19-AUG-16
NA/EMR700623-541/C02-0002
Page 4 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-19 End Date:2016-08-20
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



19-AUG-16
NA/EMR700623-541/C02-0118
Page 5 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-19 End Date:2016-08-20
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



19-AUG-16
NA/EMR700623-541/C04-0087
Page 6 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-19 End Date:2016-08-20
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



19-AUG-16
NA/EMR700623-541/C04-0171
Page 7 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-19 End Date:2016-08-20
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



19-AUG-16
Ying Zhong/EMR700623-541/C05-0001
Page 8 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-19 End Date:2016-08-20
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



19-AUG-16
Ying Zhong/EMR700623-541/C05-0010
Page 9 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-19 End Date:2016-08-20
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



19-AUG-16
Ying Zhong/EMR700623-541/C05-0013
Page 10 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-19 End Date:2016-08-20
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



19-AUG-16
Ying Zhong/EMR700623-541/C05-0021
Page 11 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-19 End Date:2016-08-20
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



19-AUG-16
Ying Zhong/EMR700623-541/C05-0041
Page 12 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-19 End Date:2016-08-20
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



19-AUG-16
Ying Zhong/EMR700623-541/C05-0056
Page 13 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-19 End Date:2016-08-20
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



19-AUG-16
Ying Zhong/EMR700623-541/C05-0068
Page 14 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-19 End Date:2016-08-20
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



19-AUG-16
Ying Zhong/EMR700623-541/C05-0117
Page 15 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-19 End Date:2016-08-20
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



19-AUG-16
Ying Zhong/EMR700623-541/C05-0141
Page 16 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-19 End Date:2016-08-20
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



19-AUG-16
NA/EMR700623-541/k01-0059
Page 17 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-19 End Date:2016-08-20
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



19-AUG-16
NA/EMR700623-541/k01-035
Page 18 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-19 End Date:2016-08-20
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



19-AUG-16
NA/EMR700623-541/k01-036
Page 19 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-19 End Date:2016-08-20
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



19-AUG-16
NA/EMR700623-541/k01-040
Page 20 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-19 End Date:2016-08-20
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



19-AUG-16
NA/EMR700623-541/k01-049
Page 21 of41
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-08-19 End Date:2016-08-20
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



19-AUG-16
NA/EMR700623-541/k01-050
Page 22 of41