Non Serious Adverse Drug Reactions Report |
| Start Date:2015-10-22 End Date:2015-10-29 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0008 | Subject Initials :R-H | DOB :02/06/1993 | Sex:Female | Race:Asian | Height:158cm | Weight:51.0kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/11/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/27/2015 | 06/05/2015 | | 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 |
| laparoscope hydrotubation | Uk-Unk-2013 | Not on treatment/medication | |
| |
Non Serious Adverse Drug Reactions Report |
| Start Date:2015-10-22 End Date:2015-10-29 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0124 | Subject Initials :Y-C | DOB :07/17/1982 | Sex:Female | Race:Asian | Height:150cm | Weight:48.5kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/21/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 06/07/2015 | 06/12/2015 | | 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 obstruction and hydrocephalus right salpingitis | Uk-Unk-2013 | Not on treatment/medication | |
| Hysteroscopy normal | Uk-Mar-2015 | Not on treatment/medication | |
| |