Non Serious Adverse Drug Reactions Report
Start Date:2016-05-30 End Date:2016-05-31
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0024	Subject Initials :HXG	DOB :10/06/1992	Sex:Female	Race:Asian	Height:150cm	Weight:55.0kg
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: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

				30-MAY-16
				NA/EMR700623-541/C02-0024
				Page 1 of65

Non Serious Adverse Drug Reactions Report
Start Date:2016-05-30 End Date:2016-05-31
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0028	Subject Initials :XHL	DOB :04/12/1981	Sex:Female	Race:Asian	Height:158cm	Weight:65.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/12/2015		225
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: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
Left abdominal ectopic pregnancy salpingectomy				Uk-Unk-2002	Not on treatment/medication
Right next laparoscopic tubal ectopic pregnancy surgery				Uk-Unk-2010	Not on treatment/medication
Conservative treatment of ectopic pregnancy				Uk-Unk-2004	Not on treatment/medication
Conservative treatment of ectopic pregnancy				Uk-Unk-2005	Not on treatment/medication

				30-MAY-16
				NA/EMR700623-541/C02-0028
				Page 2 of65

Non Serious Adverse Drug Reactions Report
Start Date:2016-05-30 End Date:2016-05-31
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0045	Subject Initials :H-T	DOB :09/08/1983	Sex:Female	Race:Asian	Height:158cm	Weight:57.5kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/13/2015		250
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
Hysteroscopic polypectomy				Uk-Aug-2014	Not on treatment/medication

				30-MAY-16
				NA/EMR700623-541/C02-0045
				Page 3 of65

Non Serious Adverse Drug Reactions Report
Start Date:2016-05-30 End Date:2016-05-31
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0063	Subject Initials :HMC	DOB :07/25/1981	Sex:Female	Race:Asian	Height:162cm	Weight:50.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/15/2015		250
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	05/29/2015	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
Hysteroscopic surgery through liquid				Uk-Unk-2014	Not on treatment/medication

				30-MAY-16
				NA/EMR700623-541/C02-0063
				Page 4 of65

Non Serious Adverse Drug Reactions Report
Start Date:2016-05-30 End Date:2016-05-31
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0083	Subject Initials :Y-L	DOB :08/20/1988	Sex:Female	Race:Asian	Height:158cm	Weight:54.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/18/2015		150
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 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 sticky points left salpingostomy				Uk-Unk-2013	Not on treatment/medication

				30-MAY-16
				NA/EMR700623-541/C02-0083
				Page 5 of65

Non Serious Adverse Drug Reactions Report
Start Date:2016-05-30 End Date:2016-05-31
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0086	Subject Initials :YZZ	DOB :07/07/1987	Sex:Female	Race:Asian	Height:150cm	Weight:55.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/18/2015		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 occurs canceled embryo transfer, OHSS improvement
Subject received concomitant medications:
Does the subject have any relevant past or present medical conditions:No
Condition				Start Date	Related to study condition	Ongoing

				30-MAY-16
				NA/EMR700623-541/C02-0086
				Page 6 of65

Non Serious Adverse Drug Reactions Report
Start Date:2016-05-30 End Date:2016-05-31
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0088	Subject Initials :HLK	DOB :06/14/1986	Sex:Female	Race:Asian	Height:159cm	Weight:59.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/18/2015		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: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
Palace laparoscopic pelvic surgery sticky points, bilateral tubal plastic surgery, endometriosis lesions fulguration.				Uk-Unk-2012	Not on treatment/medication

				30-MAY-16
				NA/EMR700623-541/C02-0088
				Page 7 of65

Non Serious Adverse Drug Reactions Report
Start Date:2016-05-30 End Date:2016-05-31
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0089	Subject Initials :XYZ	DOB :06/12/1986	Sex:Female	Race:Asian	Height:152cm	Weight:48.5kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/18/2015		187.5
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/04/2015	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
Sticky points pelvic laparoscopy surgery, tubal surgery to clear				Uk-Nov-2012	Not on treatment/medication

				30-MAY-16
				NA/EMR700623-541/C02-0089
				Page 8 of65

Non Serious Adverse Drug Reactions Report
Start Date:2016-05-30 End Date:2016-05-31
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0095	Subject Initials :MLG	DOB :08/19/1990	Sex:Female	Race:Asian	Height:155cm	Weight:54.0kg
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	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:No
Condition				Start Date	Related to study condition	Ongoing

				30-MAY-16
				NA/EMR700623-541/C02-0095
				Page 9 of65

Non Serious Adverse Drug Reactions Report
Start Date:2016-05-30 End Date:2016-05-31
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0103	Subject Initials :CPZ	DOB :05/12/1989	Sex:Female	Race:Asian	Height:165cm	Weight:63.5kg
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	06/02/2015	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
The right side of the open line on the right side of salpingectomy tubal pregnancy				Uk-Unk-2011	Not on treatment/medication

				30-MAY-16
				NA/EMR700623-541/C02-0103
				Page 10 of65

Non Serious Adverse Drug Reactions Report
Start Date:2016-05-30 End Date:2016-05-31
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0111	Subject Initials :CXW	DOB :10/10/1979	Sex:Female	Race:Asian	Height:162cm	Weight:68.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/20/2015		200
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/02/2015	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 left fallopian tube embryo window.				Uk-Unk-2012	Not on treatment/medication
Tubal lipiodol angiography				Uk-Unk-2013	Not on treatment/medication

				30-MAY-16
				NA/EMR700623-541/C02-0111
				Page 11 of65

Non Serious Adverse Drug Reactions Report
Start Date:2016-05-30 End Date:2016-05-31
Study :EMR700623-541	Investigator :Ying Zhong		Country of Investigator :China	SiteNo:C05
Subject No :C05-0041	Subject Initials :W-Y	DOB :07/03/1981	Sex:Female	Race:Asian	Height:153cm	Weight:55kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	08/08/2015		150
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	08/23/2015	08/28/2015		Related	Mild
Causality Factors		Action Taken with Study Treatment	Other action taken	Outcome	AE Special Interest	AE dose limiting toxicity
Protocol procedure,Concomitant medication(Othervalue:)		Dose not changed	Led to study termination	Resolved
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
Condition				Start Date	Related to study condition	Ongoing

				30-MAY-16
				Ying Zhong/EMR700623-541/C05-0041
				Page 12 of65

Non Serious Adverse Drug Reactions Report
Start Date:2016-05-30 End Date:2016-05-31
Study :EMR700623-541	Investigator :Ying Zhong		Country of Investigator :China	SiteNo:C05
Subject No :C05-0056	Subject Initials :X-P	DOB :06/14/1983	Sex:Female	Race:Asian	Height:158cm	Weight:46kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	08/13/2015		150
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	08/27/2015	08/29/2015		Related	Mild
Causality Factors		Action Taken with Study Treatment	Other action taken	Outcome	AE Special Interest	AE dose limiting toxicity
Protocol procedure,Concomitant medication(Othervalue:)		Not applicable	Led to study termination	Resolved
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
Condition				Start Date	Related to study condition	Ongoing

				30-MAY-16
				Ying Zhong/EMR700623-541/C05-0056
				Page 13 of65