Non Serious Adverse Drug Reactions Report
Start Date:2016-02-03 End Date:2016-02-22
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0002	Subject Initials :LLL	DOB :02/12/1987	Sex:Female	Race:Asian	Height:158cm	Weight:50.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/08/2015		150
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	05/25/2015	06/03/2015		Related	Moderate
Causality Factors		Action Taken with Study Treatment	Other action taken	Outcome	AE Special Interest	AE dose limiting toxicity
None(Othervalue:)		Not applicable	Led to study termination	Resolved
Event description:
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
Condition				Start Date	Related to study condition	Ongoing
salpingemphrxis,lalace peritoneoscope				Uk-Jul-2014	Not on treatment/medication

Non Serious Adverse Drug Reactions Report
Start Date:2016-02-03 End Date:2016-02-22
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0011	Subject Initials :P-X	DOB :12/07/1994	Sex:Female	Race:Asian	Height:160cm	Weight:60.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/11/2015		150
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	05/27/2015	06/03/2015		Related	Moderate
Causality Factors		Action Taken with Study Treatment	Other action taken	Outcome	AE Special Interest	AE dose limiting toxicity
None(Othervalue:)		Not applicable	Led to study termination	Resolved
Event description:
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
Condition				Start Date	Related to study condition	Ongoing
ectopic pregnancy Salping ectomy				Uk-Unk-2013	On treatment/medication

Non Serious Adverse Drug Reactions Report
Start Date:2016-02-03 End Date:2016-02-22
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0023	Subject Initials :JYF	DOB :11/10/1981	Sex:Female	Race:Asian	Height:163cm	Weight:70.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/12/2015		300
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	05/30/2015	06/05/2015		Related	Moderate
Causality Factors		Action Taken with Study Treatment	Other action taken	Outcome	AE Special Interest	AE dose limiting toxicity
None(Othervalue:)		Not applicable	Led to study termination	Resolved
Event description:
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
Condition				Start Date	Related to study condition	Ongoing
Hysteroscopy Salpingemphraxis				Uk-Mar-2015	Not on treatment/medication

Non Serious Adverse Drug Reactions Report
Start Date:2016-02-03 End Date:2016-02-22
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0026	Subject Initials :HCJ	DOB :07/07/1993	Sex:Female	Race:Asian	Height:161cm	Weight:53.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/12/2015		200
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	05/30/2015	06/05/2015		Related	Moderate
Causality Factors		Action Taken with Study Treatment	Other action taken	Outcome	AE Special Interest	AE dose limiting toxicity
None(Othervalue:)		Not applicable	Led to study termination	Resolved
Event description:
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
Condition				Start Date	Related to study condition	Ongoing
Laparotomy with left tubal ectopic pregnancy resection				Uk-Unk-2011	Not on treatment/medication
Under ectopic pregnancy laparoscopic conservative surgery				Uk-Unk-2012	Not on treatment/medication

Non Serious Adverse Drug Reactions Report
Start Date:2016-02-03 End Date:2016-02-22
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0029	Subject Initials :XLX	DOB :06/08/1981	Sex:Female	Race:Asian	Height:158cm	Weight:70.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/12/2015		250
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/01/2015	06/07/2015		Related	Moderate
Causality Factors		Action Taken with Study Treatment	Other action taken	Outcome	AE Special Interest	AE dose limiting toxicity
None(Othervalue:)		Not applicable	Led to study termination	Resolved
Event description:
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
Condition				Start Date	Related to study condition	Ongoing
Pelvic mass laparoscopic pelvic surgery sticky points, bilateral tubal ostomy, left ovarian drilling, tubal.				Uk-Unk-2013	Not on treatment/medication

Non Serious Adverse Drug Reactions Report
Start Date:2016-02-03 End Date:2016-02-22
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0034	Subject Initials :L-Z	DOB :09/04/1981	Sex:Female	Race:Asian	Height:156cm	Weight:53.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/13/2015		150
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	05/30/2015	06/05/2015		Related	Moderate
Causality Factors		Action Taken with Study Treatment	Other action taken	Outcome	AE Special Interest	AE dose limiting toxicity
None(Othervalue:)		Not applicable	Led to study termination	Resolved
Event description:
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:No
Condition				Start Date	Related to study condition	Ongoing

Non Serious Adverse Drug Reactions Report
Start Date:2016-02-03 End Date:2016-02-22
Study :EMR200136_583	Investigator :NA		Country of Investigator :Romania	SiteNo:006
Subject No :006-0005	Subject Initials :	DOB :08/28/1965	Sex:Female	Race:Caucasian	Height:165(cm)	Weight:70(kg)
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Visit 2 (Month 3)	03/11/2015		8
Visit 1/ Baseline (Day 1)	03/11/2015		8
Visit 4 (Month 9)	03/11/2015		8
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
increased liver enzimes	06/11/2015			Suspected	Mild
Causality Factors		Action Taken with Study Treatment	Other action taken	Outcome	AE Special Interest	AE dose limiting toxicity
None(Othervalue:)		Dose not changed	None	Ongoing
Event description:
Subject received concomitant medications:Yes
Name of medication	Start Date	Ongoing	End Date	Dose	Unit	Frequency
desloratadinum	08/22/2015		09/09/2015	5	miligrams	qd
liv 52	08/22/2015	Yes		275	miligrams	qd
Does the subject have any relevant past or present medical conditions:Yes
Condition				Start Date	Related to study condition	Ongoing
thrombophilia						Yes
arterial hipertension						Yes
peripheral artheriopathy						Yes

Non Serious Adverse Drug Reactions Report