Non Serious Adverse Drug Reactions Report |
| Start Date:2016-04-12 End Date:2016-04-13 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0224 | Subject Initials :JXL | DOB :11/11/1985 | Sex:Female | Race:Asian | Height:158cm | Weight:52.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/01/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/19/2015 | 09/25/2015 | | 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 occlusion in the left effusion | Uk-Unk-2014 | Not on treatment/medication | |
| Laparoscopic pelvic adhesions dissection and bilateral tubal fluid plastic ostomy, hysteroscopic resection of endometrial polyps palace | Uk-Unk-2014 | Not on treatment/medication | |
| |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-04-12 End Date:2016-04-13 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0226 | Subject Initials :BQX | DOB :07/10/1987 | Sex:Female | Race:Asian | Height:160cm | Weight:53.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/01/2015 | 187.5 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/17/2015 | 09/22/2015 | | 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 classification pelvic adhesions, tubal fluid prosthetics | Uk-Unk-2010 | Not on treatment/medication | |
| Laparoscopic surgery classification pelvic adhesions, tubal fluid prosthetics | Uk-Unk-2011 | Not on treatment/medication | |
| |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-04-12 End Date:2016-04-13 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0227 | Subject Initials :YXZ | DOB :12/09/1985 | Sex:Female | Race:Asian | Height:164cm | Weight:56.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/01/2015 | 187.5 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/17/2015 | 09/22/2015 | | 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 |
| Abdominal ectopic pregnancy conservative surgery. | Uk-Unk-2012 | Not on treatment/medication | |
| Ectopic pregnancy laparoscopic conservative surgery. | Uk-Unk-2013 | Not on treatment/medication | |
| HSG: incomplete right fallopian tube obstruction, left fallopian tube fluid. | Uk-Unk-2014 | Not on treatment/medication | |
| |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-04-12 End Date:2016-04-13 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0228 | Subject Initials :J-X | DOB :09/12/1981 | Sex:Female | Race:Asian | Height:160cm | Weight:51.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/02/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/20/2015 | 09/25/2015 | | 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: right fallopian tube obstruction. | Uk-Unk-2013 | Not on treatment/medication | |
| |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-04-12 End Date:2016-04-13 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0229 | Subject Initials :HYT | DOB :11/13/1992 | Sex:Female | Race:Asian | Height:153cm | Weight:45.5kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/02/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/18/2015 | 09/24/2015 | | 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 occlusion | Uk-Unk-2013 | Not on treatment/medication | |
| Laparoscopic surgery: pelvic adhesions dissection, tubal plasty, uterine fibroids dug surgery, uterine suspension surgery. | Uk-Unk-2013 | Not on treatment/medication | |
| Hysteroscopy normal | Uk-Unk-2015 | Not on treatment/medication | |
| |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-04-12 End Date:2016-04-13 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0230 | Subject Initials :F-X | DOB :07/08/1987 | Sex:Female | Race:Asian | Height:156cm | Weight:51.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/02/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/18/2015 | 09/24/2015 | | 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 |
| Caesarean section | Uk-Unk-2009 | Not on treatment/medication | |
| HSG: bilateral tubal occlusion | Uk-Mar-2015 | Not on treatment/medication | |
| Hysteroscopy normal | Uk-Unk-2015 | Not on treatment/medication | |
| |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-04-12 End Date:2016-04-13 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0231 | Subject Initials :LJS | DOB :08/28/1981 | Sex:Female | Race:Asian | Height:160cm | Weight:69.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/02/2015 | 300 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/17/2015 | 09/24/2015 | | 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 passable | Uk-Unk-2013 | Not on treatment/medication | |
| Palace laparoscopy | Uk-Unk-2014 | Not on treatment/medication | |
| |