Non Serious Adverse Drug Reactions Report |
| Start Date:2016-05-12 End Date:2016-05-13 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0059 | Subject Initials :J-L | DOB :12/23/1984 | Sex:Female | Race:Asian | Height:155cm | 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 | 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 |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-05-12 End Date:2016-05-13 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0062 | Subject Initials :FQR | DOB :07/25/1983 | Sex:Female | Race:Asian | Height:162cm | Weight:46.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/14/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/30/2015 | 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 |
| Hysteroscopic tubal inspection | Uk-May-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-05-12 End Date:2016-05-13 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0071 | Subject Initials :LLX | DOB :07/13/1987 | 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 | 05/15/2015 | 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:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| Laparoscopic pelvic sub sticky, sticky points left fallopian tube surgery. | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-05-12 End Date:2016-05-13 |
| 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 | 06/05/2015 | 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 | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-05-12 End Date:2016-05-13 |
| 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 | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-05-12 End Date:2016-05-13 |
| 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 | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-05-12 End Date:2016-05-13 |
| 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 | |