Non Serious Adverse Drug Reactions Report |
| Start Date:2016-04-08 End Date:2016-04-11 |
| 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: |
| 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 | |
| |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-04-08 End Date:2016-04-11 |
| 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: |
| 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 | |
| |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-04-08 End Date:2016-04-11 |
| 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: |
| 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 | |
| |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-04-08 End Date:2016-04-11 |
| 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: |
| 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 | |
| |