Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
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: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
salpingemphrxis,lalace peritoneoscope				Uk-Jul-2014	Not on treatment/medication

				28-APR-16
				NA/EMR700623-541/C02-0002
				Page 1 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
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

				26-APR-16
				NA/EMR700623-541/C02-0095
				Page 2 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
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

				26-APR-16
				NA/EMR700623-541/C02-0102
				Page 3 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
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 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
The right side of the open line on the right side of salpingectomy tubal pregnancy				Uk-Unk-2011	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0103
				Page 4 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
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

				26-APR-16
				NA/EMR700623-541/C02-0111
				Page 5 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0115	Subject Initials :KJT	DOB :07/02/1988	Sex:Female	Race:Asian	Height:163cm	Weight:52.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/21/2015		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
HSG examination: bilateral tubal occlusion				Uk-Unk-2012	Not on treatment/medication
Laparoscopy surgery: pelvic sticky points, bilateral tubal ostomy + right side mesosalpinx cyst removal.				Uk-May-2015	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0115
				Page 6 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0118	Subject Initials :MLF	DOB :08/03/1984	Sex:Female	Race:Asian	Height:160cm	Weight:55.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/21/2015		150
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/07/2015	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:Yes
Condition				Start Date	Related to study condition	Ongoing
HSG: bilateral tubal obstruction				Uk-Unk-2007	Not on treatment/medication
Laparoscopic pelvic sticky points, bilateral ovarian drilling				Uk-Unk-2007	Not on treatment/medication
Cervical biopsy showing inflammation				Uk-Unk-2015	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0118
				Page 7 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0124	Subject Initials :Y-C	DOB :07/17/1982	Sex:Female	Race:Asian	Height:150cm	Weight:48.5kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/21/2015		225
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/07/2015	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: the left fallopian tube obstruction and hydrocephalus right salpingitis				Uk-Unk-2013	Not on treatment/medication
Hysteroscopy normal				Uk-Mar-2015	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0124
				Page 8 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0126	Subject Initials :RCM	DOB :01/09/1989	Sex:Female	Race:Asian	Height:165cm	Weight:60.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/21/2015		150
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/07/2015	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: the right fallopian tube obstruction, poor uterine shape				Uk-Unk-2013	Not on treatment/medication
Hysteroscopy: uterine spindle-shaped, single horn.				Uk-Unk-2014	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0126
				Page 9 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0134	Subject Initials :QYL	DOB :06/17/1986	Sex:Female	Race:Asian	Height:155cm	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	06/06/2015	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 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
Laparotomy: pelvic abscess incision and drainage, the right accessories cystectomy				Uk-Unk-2009	Not on treatment/medication
Hysteroscopy normal uterine shape				Uk-Unk-2013	Not on treatment/medication
Hysteroscopic curettage				Uk-Unk-2015	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0134
				Page 10 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
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

				26-APR-16
				NA/EMR700623-541/C02-0136
				Page 11 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
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

				26-APR-16
				NA/EMR700623-541/C02-0137
				Page 12 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
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

				26-APR-16
				NA/EMR700623-541/C02-0138
				Page 13 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0142	Subject Initials :HMT	DOB :02/19/1988	Sex:Female	Race:Asian	Height:168cm	Weight:46.0kg
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	06/07/2015	06/12/2015		Related	Moderate
Causality Factors		Action Taken with Study Treatment	Other action taken	Outcome	AE Special Interest	AE dose limiting toxicity
Other(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 and hydrocephalus				Uk-Unk-2014	Not on treatment/medication
Laparoscopy surgery: pelvic stars stick + fulguration of endometriosis foci, tubal plastic surgery				Uk-Unk-2014	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0142
				Page 14 of 43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0143	Subject Initials :F-L	DOB :11/06/1982	Sex:Female	Race:Asian	Height:155cm	Weight:51.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/22/2015		225
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/08/2015	06/14/2015		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: the left fallopian tube obstruction, incomplete right fallopian tube obstruction				Uk-Unk-2012	Not on treatment/medication
Laparoscopy surgery: pelvic stars stick + tubal surgery, endometriosis lesions fulguration				Uk-Unk-2012	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0143
				Page 15 of 43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
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

				26-APR-16
				NA/EMR700623-541/C02-0153
				Page 16 of 43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0157	Subject Initials :Y-Z	DOB :07/22/1984	Sex:Female	Race:Asian	Height:156cm	Weight:55.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/25/2015		200
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 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-2010	Not on treatment/medication
Laparoscopic Surgery: Tubal clear.				Uk-Unk-2007	Not on treatment/medication
Ectopic pregnancy laparoscopic surgery: tubal embryo window.				Uk-Jan-2014	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0157
				Page 17 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0161	Subject Initials :H-Y	DOB :12/12/1985	Sex:Female	Race:Asian	Height:166cm	Weight:57.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/26/2015		150
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:Yes
Condition				Start Date	Related to study condition	Ongoing
HSG: bilateral tubal obstruction				Uk-Unk-2007	Not on treatment/medication
Laparoscopic tubal surgery sticking points.				Uk-Unk-2007	Not on treatment/medication
Open left fallopian tube ectopic pregnancy surgery				Uk-Unk-2012	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0161
				Page 18 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0164	Subject Initials :AHC	DOB :12/12/1982	Sex:Female	Race:Asian	Height:156cm	Weight:49.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/26/2015		150
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/12/2015	06/20/2015		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 side				Uk-Unk-2012	Not on treatment/medication
Laparoscopy Surgery: salpingostomy, pelvic adhesions dissection.				Uk-Unk-2012	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0164
				Page 19 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0169	Subject Initials :L-W	DOB :06/08/1985	Sex:Female	Race:Asian	Height:166cm	Weight:50.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/27/2015		150
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/12/2015	06/20/2015		Related	Moderate
Causality Factors		Action Taken with Study Treatment	Other action taken	Outcome	AE Special Interest	AE dose limiting toxicity
None(Othervalue:)		Not applicable	None	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 insufficiency				Uk-Jun-2014	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0169
				Page 20 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0174	Subject Initials :YXC	DOB :06/04/2015	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	05/27/2015		150
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/12/2015	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
Laparoscopic surgery: left ovarian endometriosis cystectomy				Uk-Unk-2010	Not on treatment/medication
HSG: the left fallopian tube obstruction, right fallopian tube inflammation.				Uk-Unk-2012	Not on treatment/medication
Laparoscopic surgery: pelvic adhesions dissection, left fallopian tube plastic surgery				Uk-Unk-2012	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0174
				Page 21 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0175	Subject Initials :L-T	DOB :02/15/1989	Sex:Female	Race:Asian	Height:158cm	Weight:40.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/27/2015		150
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/11/2015	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:Yes
Condition				Start Date	Related to study condition	Ongoing
HSG: bilateral tubal obstruction.				Uk-Aug-2014	Not on treatment/medication
Laparoscopy surgery: pelvic adhesions dissection, tubal plastic surgery to repair the left corpus luteum cyst cystectomy,				Uk-Unk-2014	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0175
				Page 22 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0176	Subject Initials :KBF	DOB :05/19/1986	Sex:Female	Race:Asian	Height:160cm	Weight:57.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/27/2015		200
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/11/2015	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
Tubal examination: passable				Uk-Unk-2008	Not on treatment/medication
HSG: bilateral tubal occlusion				Uk-Unk-2009	Not on treatment/medication
Laparoscopy surgery: bilateral tubal repair plastic surgery, pelvic adhesions dissection				Uk-Unk-2011	Not on treatment/medication
Ectopic pregnancy: open surgery				Uk-Unk-2012	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0176
				Page 23 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0178	Subject Initials :XSC	DOB :10/11/1988	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	05/27/2015		200
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:Yes
Condition				Start Date	Related to study condition	Ongoing
HSG: bilateral tubal resistance.				Uk-Jan-2013	Not on treatment/medication
Laparoscopy surgery: pelvic adhesions dissection, bilateral salpingo-repair plastic surgery, normal uterine shape.				Uk-Jan-2013	Not on treatment/medication
Hysteroscopy normal, water surgery: incomplete right fallopian tube obstruction				Uk-Feb-2015	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0178
				Page 24 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0179	Subject Initials :HYZ	DOB :05/14/1991	Sex:Female	Race:Asian	Height:158cm	Weight:53.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/27/2015		150
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/11/2015	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
Ectopic pregnancy laparotomy: the left fallopian tube removal.				Uk-Unk-2009	Not on treatment/medication
Abdominal ectopic pregnancy conservative surgery.				Uk-Unk-2010	Not on treatment/medication
Hysteroscopy: endometrial polyp excision.				Uk-Jan-2015	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0179
				Page 25 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0180	Subject Initials :YPW	DOB :08/20/1982	Sex:Female	Race:Asian	Height:156cm	Weight:57.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/27/2015		225
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/13/2015	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:Yes
Condition				Start Date	Related to study condition	Ongoing
Ectopic pregnancy: treatment of chemical drugs to kill embryos				Uk-Unk-2012	Not on treatment/medication
HSG: bilateral tubal occlusion				Uk-Unk-2008	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0180
				Page 26 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0185	Subject Initials :YMX	DOB :09/07/1975	Sex:Female	Race:Asian	Height:159cm	Weight:63.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/28/2015		225
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/15/2015	06/20/2015		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-2013	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0185
				Page 27 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0190	Subject Initials :F-H	DOB :03/09/1984	Sex:Female	Race:Asian	Height:160cm	Weight:55.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/28/2015		150
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/12/2015	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

				26-APR-16
				NA/EMR700623-541/C02-0190
				Page 28 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0191	Subject Initials :SYZ	DOB :02/16/1983	Sex:Female	Race:Asian	Height:162cm	Weight:58.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/28/2015		200
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/14/2015	06/18/2015		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
HSG: bilateral tubal occlusion with effusion				Uk-Unk-2008	Not on treatment/medication
Tubal treatment: Tips patency				Uk-Unk-2008	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0191
				Page 29 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0195	Subject Initials :J-L	DOB :08/15/1984	Sex:Female	Race:Asian	Height:156cm	Weight:48.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/28/2015		150
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/14/2015	06/18/2015		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 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 patency, pelvic adhesions.				Uk-Unk-2012	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0195
				Page 30 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0200	Subject Initials :L-Z	DOB :12/17/1988	Sex:Female	Race:Asian	Height:155cm	Weight:70.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	05/28/2015		187.5
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	06/13/2015	06/18/2015		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
HSG: bilateral obstruction				Uk-Apr-2014	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0200
				Page 31 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0202	Subject Initials :F-Q	DOB :06/09/1985	Sex:Female	Race:Asian	Height:159cm	Weight:65.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	08/27/2015		150
Adverse Event	Start Date	End Date	Time related to study treatment	Causality to study drug	Severity
OHSS	09/11/2015	09/16/2015		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:Yes
Condition				Start Date	Related to study condition	Ongoing
HSG: bilateral tubal patency				Uk-Unk-2013	Not on treatment/medication
Laparoscopic surgery: pelvic adhesions dissection, bilateral mesosalpinx cystectomy				Uk-Unk-2014	Not on treatment/medication
Tubal examination: smooth				Uk-Unk-2014	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0202
				Page 32 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0206	Subject Initials :YPZ	DOB :10/20/1980	Sex:Female	Race:Asian	Height:150cm	Weight:47.0kg
First administration date of batch :			Batch number :
Study Drug	Start Date		Dose	Change in Dose
Gonal-f New Pen Stimulation Treatment	08/28/2015		187.5
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
HSG: bilateral tubal occlusion				Uk-Unk-2011	Not on treatment/medication
Laparoscopy surgery: pelvic adhesions dissection, bilateral tubal surgery to clear.				Uk-Unk-2011	Not on treatment/medication
HSG: bilateral tubal occlusion				Uk-Unk-2013	Not on treatment/medication
Laparoscopy surgery: pelvic adhesions dissection, uterine fibroids dug surgery, tubal surgery to clear, coherent liquid skill.				Uk-Unk-2013	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0206
				Page 33 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
Study :EMR700623-541	Investigator :NA		Country of Investigator :China	SiteNo:C02
Subject No :C02-0207	Subject Initials :JHZ	DOB :09/03/2015	Sex:Female	Race:Asian	Height:160cm	Weight:55.0kg
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	09/13/2015	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 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: Left salpingectomy				Uk-Unk-2011	Not on treatment/medication
Ectopic pregnancy laparoscopic surgery: Right salpingectomy				Uk-Unk-2013	Not on treatment/medication
HSG: bilateral tubal occlusion				Uk-Unk-2014	Not on treatment/medication

				26-APR-16
				NA/EMR700623-541/C02-0207
				Page 34 of43

Non Serious Adverse Drug Reactions Report
Start Date:2016-04-26 End Date:2016-04-29
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

				26-APR-16
				NA/EMR700623-541/C02-0208
				Page 35 of43