Non Serious Adverse Drug Reactions Report |
| Start Date:2016-04-04 End Date:2016-04-05 |
| 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: |
| 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 | |
| |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-04-04 End Date:2016-04-05 |
| 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: |
| 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 | |
| |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-04-04 End Date:2016-04-05 |
| 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: |
| 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 | |
| |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-04-04 End Date:2016-04-05 |
| 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: |
| 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 | |
| |