Non Serious Adverse Drug Reactions Report |
| Start Date:2016-03-30 End Date:2016-03-31 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0157 | Subject Initials :Y-Z | DOB :07/22/1984 | Sex:Female | Race:Asian | Height:156cm | Weight:55.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/25/2015 | 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 obstruction | Uk-Unk-2010 | Not on treatment/medication | |
| Laparoscopic Surgery: Tubal clear. | Uk-Unk-2007 | Not on treatment/medication | |
| Ectopic pregnancy laparoscopic surgery: tubal embryo window. | Uk-Jan-2014 | Not on treatment/medication | |
| |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-03-30 End Date:2016-03-31 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0161 | Subject Initials :H-Y | DOB :12/12/1985 | Sex:Female | Race:Asian | Height:166cm | Weight:57.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/26/2015 | 150 | |
| 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 obstruction | Uk-Unk-2007 | Not on treatment/medication | |
| Laparoscopic tubal surgery sticking points. | Uk-Unk-2007 | Not on treatment/medication | |
| Open left fallopian tube ectopic pregnancy surgery | Uk-Unk-2012 | Not on treatment/medication | |
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