Non Serious Adverse Drug Reactions Report |
| Start Date:2016-04-01 End Date:2016-04-04 |
| 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: |
| 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 | |
| |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-04-01 End Date:2016-04-04 |
| 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: |
| 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 | |
| |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-04-01 End Date:2016-04-04 |
| 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: |
| 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 | |
| |