Non Serious Adverse Drug Reactions Report
Start Date:2016-05-11 End Date:2016-05-12
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0051	Subject Initials :yqx	DOB :01/15/1983	Sex:Female	Race:Asian	Height:154cm	Weight:50.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/14/2015		225
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	05/31/2015	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:Moderate OHSS occurs canceled embryo transfer, OHSS improvement
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
Condition				Start Date	Related to study condition	Ongoing
salpingemphraxis,laparoscopic operation				Uk-Unk-2012	Not on treatment/medication

				11-MAY-16
				NA/EMR700623-541/C02-0051
				Page 1 of10

Non Serious Adverse Drug Reactions Report
Start Date:2016-05-11 End Date:2016-05-12
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0060	Subject Initials :Y-W	DOB :11/10/1981	Sex:Female	Race:Asian	Height:150cm	Weight:45.5kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/14/2015		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:Moderate OHSS patients, improved canceled after embryo transfer.
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 pelvic sticking points, ovarian drilling, tubal surgery to clear.				Uk-Unk-2014	Not on treatment/medication

				11-MAY-16
				NA/EMR700623-541/C02-0060
				Page 2 of10

Non Serious Adverse Drug Reactions Report
Start Date:2016-05-11 End Date:2016-05-12
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0061	Subject Initials :T-D	DOB :02/15/1988	Sex:Female	Race:Asian	Height:161cm	Weight:60.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/14/2015		150
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	05/28/2015	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:Moderate OHSS occurs canceled embryo transfer, OHSS improvement
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
Condition				Start Date	Related to study condition	Ongoing
salpingemphraxis,laparoscopic operation				Uk-Unk-2014	Not on treatment/medication

				11-MAY-16
				NA/EMR700623-541/C02-0061
				Page 3 of10

Non Serious Adverse Drug Reactions Report
Start Date:2016-05-11 End Date:2016-05-12
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	06/01/2015	06/12/2015		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:Moderate OHSS patients, improved canceled after embryo transfer.
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

				11-MAY-16
				NA/EMR700623-541/C02-0102
				Page 4 of10

Non Serious Adverse Drug Reactions Report
Start Date:2016-05-11 End Date:2016-05-12
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0136	Subject Initials :Q-L	DOB :03/28/1984	Sex:Female	Race:Asian	Height:154cm	Weight:47.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/22/2015		200
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/08/2015	06/12/2015		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:Moderate OHSS patients, improved canceled after embryo transfer.
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
Condition				Start Date	Related to study condition	Ongoing
HSG: bilateral tubal obstruction incomplete				Uk-Unk-2014	Not on treatment/medication

				11-MAY-16
				NA/EMR700623-541/C02-0136
				Page 5 of10

Non Serious Adverse Drug Reactions Report
Start Date:2016-05-11 End Date:2016-05-12
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0137	Subject Initials :YLF	DOB :11/01/1989	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	05/22/2015		150
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/09/2015	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	Led to study termination	Resolved
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
Condition				Start Date	Related to study condition	Ongoing
HSG: bilateral tubal obstruction				Uk-Unk-2014	Not on treatment/medication

				11-MAY-16
				NA/EMR700623-541/C02-0137
				Page 6 of10

Non Serious Adverse Drug Reactions Report
Start Date:2016-05-11 End Date:2016-05-12
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0138	Subject Initials :TTJ	DOB :06/20/1990	Sex:Female	Race:Asian	Height:150cm	Weight:41.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/22/2015		150
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/06/2015	06/12/2015		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:Moderate OHSS patients, improved canceled after embryo transfer.
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 laparoscopic surgery: the right fallopian tube embryo pelvic sticking points				Uk-Jan-2014	Not on treatment/medication
Hysteroscopy: endometrial polyps.				Uk-Feb-2015	Not on treatment/medication

				11-MAY-16
				NA/EMR700623-541/C02-0138
				Page 7 of10

Non Serious Adverse Drug Reactions Report
Start Date:2016-05-11 End Date:2016-05-12
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0153	Subject Initials :H-H	DOB :07/12/1979	Sex:Female	Race:Asian	Height:153cm	Weight:43.5kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/25/2015		250
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/10/2015	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	Led to study termination	Resolved
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
Condition				Start Date	Related to study condition	Ongoing

				11-MAY-16
				NA/EMR700623-541/C02-0153
				Page 8 of10

Non Serious Adverse Drug Reactions Report
Start Date:2016-05-11 End Date:2016-05-12
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0201	Subject Initials :J-L	DOB :12/15/1990	Sex:Female	Race:Asian	Height:168cm	Weight:65kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	09/07/2015		225
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	09/26/2015	10/02/2015		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:Moderate OHSS occurs canceled embryo transfer, OHSS improvement
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
Condition				Start Date	Related to study condition	Ongoing
HSG: bilateral tubal occlusion				Uk-Unk-2012	Not on treatment/medication

				11-MAY-16
				NA/EMR700623-541/C02-0201
				Page 9 of 10

Non Serious Adverse Drug Reactions Report
Start Date:2016-05-11 End Date:2016-05-12
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0208	Subject Initials :MQW	DOB :09/24/1988	Sex:Female	Race:Asian	Height:156cm	Weight:54.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	08/28/2015		150
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	09/14/2015	09/18/2015		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:Moderate OHSS occurs canceled embryo transfer, OHSS improvement
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:Yes
Condition				Start Date	Related to study condition	Ongoing
Hysteroscopic resection of endometrial polyps				Uk-Unk-2015	Not on treatment/medication

				11-MAY-16
				NA/EMR700623-541/C02-0208
				Page 10 of10