Non Serious Adverse Drug Reactions Report
Start Date:2015-09-24 End Date:2015-09-25
Study :EMR700623-541	Investigator :Fei Gong		Country of Investigator :China	SiteNo:C01
Subject No :C01-0001	Subject Initials :TTW	DOB :05/13/1988	Sex:Female	Race:Asian	Height:157cm	Weight:41.5kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/16/2015		112.5
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/06/2015	06/16/2015		Related	Moderate
Causality Factors		Action Taken with Study Treatment	Other action taken	Outcome	AE Special Interest	AE dose limiting toxicity
None(Othervalue:)		Not applicable	Concomitant procedure**	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
Bilateral fallopian tube obstruction				04/11/2014	Not on treatment/medication	Ongoing

				24-SEP-15
				Fei Gong/EMR700623-541/C01-0001
				Page 1 of30

Non Serious Adverse Drug Reactions Report
Start Date:2015-09-24 End Date:2015-09-25
Study :EMR700623-541	Investigator :Fei Gong		Country of Investigator :China	SiteNo:C01
Subject No :C01-0068	Subject Initials :X-S	DOB :04/16/1989	Sex:Female	Race:Asian	Height:160cm	Weight:43kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	06/26/2015		150
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	07/23/2015	08/04/2015		Related	Severe
Causality Factors		Action Taken with Study Treatment	Other action taken	Outcome	AE Special Interest	AE dose limiting toxicity
None(Othervalue:)		Not applicable	Concomitant procedure**	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
The left Hydrosalpinx and adhesions,less patency.Right fallopian tube partially blocked				03/22/2014	Not on treatment/medication	Ongoing
right fallopian tube resection because of Ectopic pregnancy				UK-Oct-2011	Not on treatment/medication

				24-SEP-15
				Fei Gong/EMR700623-541/C01-0068
				Page 2 of30

Non Serious Adverse Drug Reactions Report
Start Date:2015-09-24 End Date:2015-09-25
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0010	Subject Initials :Y-H	DOB :10/18/1985	Sex:Female	Race:Asian	Height:153cm	Weight:47.0kg
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	05/29/2015	06/02/2015		Related	Moderate
Causality Factors		Action Taken with Study Treatment	Other action taken	Outcome	AE Special Interest	AE dose limiting toxicity
Concomitant medication**(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

				24-SEP-15
				NA/EMR700623-541/C02-0010
				Page 3 of30

Non Serious Adverse Drug Reactions Report
Start Date:2015-09-24 End Date:2015-09-25
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0102	Subject Initials :HYD	DOB :10/14/1985	Sex:Female	Race:Asian	Height:163cm	Weight:57.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/19/2015		150
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS risk				Related	Moderate
Causality Factors		Action Taken with Study Treatment	Other action taken	Outcome	AE Special Interest	AE dose limiting toxicity
None(Othervalue:)		Not applicable	None
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
Palace laparoscopy				Uk-Unk-2013	Not on treatment/medication

				24-SEP-15
				NA/EMR700623-541/C02-0102
				Page 4 of30

Non Serious Adverse Drug Reactions Report
Start Date:2015-09-24 End Date:2015-09-25
Study :EMR700623-541	Investigator :Ying Zhong		Country of Investigator :China	SiteNo:C05
Subject No :C05-0001	Subject Initials :XFZ	DOB :01/21/1988	Sex:Female	Race:Asian	Height:159cm	Weight:50kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	08/01/2015		225
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	08/16/2015	08/18/2015		Related	Severe
Causality Factors		Action Taken with Study Treatment	Other action taken	Outcome	AE Special Interest	AE dose limiting toxicity
None(Othervalue:)		Dose not changed	Concomitant medication **	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
oophorocystectomy				UK-Jul-2013	Not on treatment/medication
salpingoplasty				UK-Feb-2014	Not on treatment/medication
salpingitis after previous tubal occlusion				UK-Feb-2014	Not on treatment/medication	Ongoing

				25-SEP-15
				Ying Zhong/EMR700623-541/C05-0001
				Page 5 of30

Non Serious Adverse Drug Reactions Report
Start Date:2015-09-24 End Date:2015-09-25
Study :EMR700623-541	Investigator :NA		Country of Investigator :Korea	SiteNo:K01
Subject No :k01-0059	Subject Initials :LKH	DOB :08/05/1981	Sex:Female	Race:Asian	Height:153cm	Weight:74kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	06/02/2015		225
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/13/2015	07/02/2015		Related	Mild
Causality Factors		Action Taken with Study Treatment	Other action taken	Outcome	AE Special Interest	AE dose limiting toxicity
None(Othervalue:)		Dose not changed	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

				24-SEP-15
				NA/EMR700623-541/k01-0059
				Page 6 of30

Non Serious Adverse Drug Reactions Report
Start Date:2015-09-24 End Date:2015-09-25
Study :EMR700623-541	Investigator :NA		Country of Investigator :Korea	SiteNo:K01
Subject No :k01-035	Subject Initials :PSS	DOB :01/19/1983	Sex:Female	Race:Asian	Height:161cm	Weight:56kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	03/11/2015		225
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	03/23/2015	04/21/2015		Related	Mild
Causality Factors		Action Taken with Study Treatment	Other action taken	Outcome	AE Special Interest	AE dose limiting toxicity
None(Othervalue:)		Dose not changed	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

				24-SEP-15
				NA/EMR700623-541/k01-035
				Page 7 of30

Non Serious Adverse Drug Reactions Report
Start Date:2015-09-24 End Date:2015-09-25
Study :EMR700623-541	Investigator :NA		Country of Investigator :Korea	SiteNo:K01
Subject No :k01-036	Subject Initials :JSY	DOB :07/28/1981	Sex:Female	Race:Asian	Height:162cm	Weight:54kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	03/13/2015		225
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	03/24/2015	04/07/2015		Related	Moderate
Causality Factors		Action Taken with Study Treatment	Other action taken	Outcome	AE Special Interest	AE dose limiting toxicity
None(Othervalue:)		Dose not changed	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

				24-SEP-15
				NA/EMR700623-541/k01-036
				Page 8 of30

Non Serious Adverse Drug Reactions Report
Start Date:2015-09-24 End Date:2015-09-25
Study :EMR700623-541	Investigator :NA		Country of Investigator :Korea	SiteNo:K01
Subject No :k01-040	Subject Initials :LBH	DOB :03/05/1985	Sex:Female	Race:Asian	Height:164cm	Weight:61kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	04/06/2015		225
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	04/15/2015	04/30/2015		Related	Mild
Causality Factors		Action Taken with Study Treatment	Other action taken	Outcome	AE Special Interest	AE dose limiting toxicity
None(Othervalue:)		Dose not changed	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

				24-SEP-15
				NA/EMR700623-541/k01-040
				Page 9 of30

Non Serious Adverse Drug Reactions Report
Start Date:2015-09-24 End Date:2015-09-25
Study :EMR700623-541	Investigator :NA		Country of Investigator :Korea	SiteNo:K01
Subject No :k01-049	Subject Initials :PGR	DOB :02/20/1983	Sex:Female	Race:Asian	Height:168cm	Weight:62kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/02/2015		300
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	05/13/2015	05/29/2015		Related	Moderate
Causality Factors		Action Taken with Study Treatment	Other action taken	Outcome	AE Special Interest	AE dose limiting toxicity
None(Othervalue:)		Dose not changed	Concomitant medication **,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
laparoscopic ovary cystectomy				UK-UNK-2004	Not on treatment/medication

				24-SEP-15
				NA/EMR700623-541/k01-049
				Page 10 of30

Non Serious Adverse Drug Reactions Report
Start Date:2015-09-24 End Date:2015-09-25
Study :EMR700623-541	Investigator :NA		Country of Investigator :Korea	SiteNo:K01
Subject No :k01-050	Subject Initials :KHG	DOB :04/22/1984	Sex:Female	Race:Asian	Height:150cm	Weight:46kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/03/2015		300
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	05/14/2015	05/29/2015		Related	Mild
Causality Factors		Action Taken with Study Treatment	Other action taken	Outcome	AE Special Interest	AE dose limiting toxicity
None(Othervalue:)		Dose not changed	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
ovary cystectomy				UK-Jan-2014	Not on treatment/medication

				24-SEP-15
				NA/EMR700623-541/k01-050
				Page 11 of30