Non Serious Adverse Drug Reactions Report

Start Date:2016-02-26 End Date:2016-03-14
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:
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



26-FEB-16
NA/EMR700623-541/C02-0043
Page 1 of293
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-02-26 End Date:2016-03-14
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:
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:No
ConditionStart DateRelated to study conditionOngoing



04-MAR-16
NA/EMR700623-541/C02-0046
Page 2 of293
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-02-26 End Date:2016-03-14
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:
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



04-MAR-16
NA/EMR700623-541/C02-0049
Page 3 of293
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-02-26 End Date:2016-03-14
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:
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:No
ConditionStart DateRelated to study conditionOngoing



04-MAR-16
NA/EMR700623-541/C02-0052
Page 4 of293
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-02-26 End Date:2016-03-14
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:
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



04-MAR-16
NA/EMR700623-541/C02-0053
Page 5 of293
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-02-26 End Date:2016-03-14
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:
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:No
ConditionStart DateRelated to study conditionOngoing



07-MAR-16
NA/EMR700623-541/C02-0059
Page 6 of293
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-02-26 End Date:2016-03-14
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:
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



07-MAR-16
NA/EMR700623-541/C02-0062
Page 7 of293
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-02-26 End Date:2016-03-14
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:
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



08-MAR-16
NA/EMR700623-541/C02-0071
Page 8 of293
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-02-26 End Date:2016-03-14
Study :EMR700623-541Investigator :NACountry of Investigator :ChinaSiteNo:C02
Subject No :C02-0115Subject Initials :KJTDOB :07/02/1988Sex:FemaleRace:AsianHeight:163cmWeight:52.0kg
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Gonal-f New Pen Stimulation Treatment05/21/2015150
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
OHSS06/06/201506/12/2015RelatedModerate
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
None(Othervalue:)Not applicableLed to study terminationResolved
Event description:
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
 



14-MAR-16
NA/EMR700623-541/C02-0115
Page 9 of 293
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-02-26 End Date:2016-03-14
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
 



01-MAR-16
Ying Zhong/EMR700623-541/C05-0010
Page 10 of 293
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-02-26 End Date:2016-03-14
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
 



01-MAR-16
Ying Zhong/EMR700623-541/C05-0013
Page 11 of 293
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-02-26 End Date:2016-03-14
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:)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 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
 



01-MAR-16
Ying Zhong/EMR700623-541/C05-0021
Page 12 of 293
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-02-26 End Date:2016-03-14
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 Treatment08/08/2015225
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
 



01-MAR-16
Ying Zhong/EMR700623-541/C05-0041
Page 13 of 293
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-02-26 End Date:2016-03-14
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
OHSS08/27/201508/29/2015RelatedModerate
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:No
ConditionStart DateRelated to study conditionOngoing
 



01-MAR-16
Ying Zhong/EMR700623-541/C05-0056
Page 14 of 293
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-02-26 End Date:2016-03-14
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
 



01-MAR-16
Ying Zhong/EMR700623-541/C05-0068
Page 15 of 293
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-02-26 End Date:2016-03-14
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
OHSS09/08/201509/10/2015RelatedModerate
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
 



01-MAR-16
Ying Zhong/EMR700623-541/C05-0117
Page 16 of 293
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-02-26 End Date:2016-03-14
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
 



01-MAR-16
Ying Zhong/EMR700623-541/C05-0141
Page 17 of 293
 

Non Serious Adverse Drug Reactions Report

Start Date:2016-02-26 End Date:2016-03-14
Study :EMR200136_583Investigator :NACountry of Investigator :RomaniaSiteNo:007
Subject No :007-0007Subject Initials :DOB :08/01/1981Sex:FemaleRace:CaucasianHeight:163(cm)Weight:60(kg)
First administration date of batch :Batch number :
Study DrugStart DateDoseChange in Dose
Visit 2 (Month 3)06/05/20159
Visit 3 (Month 6)06/05/20159
Visit 1/ Baseline (Day 1)06/05/20159
Visit 4 (Month 9)06/05/20169
Adverse EventStart DateEnd DateTime related to study treatmentCausality to study drugSeverity
Adverse event12/16/2015SuspectedMild
Causality FactorsAction Taken with Study TreatmentOther action takenOutcomeAE Special InterestAE dose limiting toxicity
Other(Othervalue:Rebif therapy)Dose not changedConcomitant medicationOngoing
Event description:
Subject received concomitant medications:Yes
Name of medicationStart DateOngoingEnd DateDoseUnitFrequency
Stilnox06/02/2015Yes1tbQD
Alanerv06/06/201511/30/20152tbBID
Acetaminophen 06/05/2015Yes500mgPRN
L-ThyroxinUk-Jan-2016Yes25mcgQD
Does the subject have any relevant past or present medical conditions:Yes
ConditionStart DateRelated to study conditionOngoing
DepressionYes



03-MAR-16
NA/EMR200136_583/007-0007
Page 18 of 293