Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-29 End Date:2016-07-30 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
| Subject No :C02-0201 | Subject Initials :J-L | DOB :12/15/1990 | Sex:Female | Race:Asian | Height:168cm | Weight:65kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/07/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/26/2015 | 10/02/2015 | | 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 occurs canceled embryo transfer, OHSS improvement |
| 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-2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-29 End Date:2016-07-30 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C04 |
| Subject No :C04-0087 | Subject Initials :HZD | DOB :08/04/1983 | Sex:Female | Race:Asian | Height:161cm | Weight:60kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 06/26/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 07/07/2015 | 07/21/2015 | | Related | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Dose reduced | None | Resolved | | |
| Event Description:none |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| spontaneous abortion | 01/05/2010 | Not on treatment/medication | |
| spontaneous abortion | 05/18/2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-29 End Date:2016-07-30 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C04 |
| Subject No :C04-0171 | Subject Initials :SHL | DOB :08/17/1987 | Sex:Female | Race:Asian | Height:154cm | Weight:40kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 09/29/2015 | 300 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 09/30/2015 | 10/09/2015 | | Related | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Dose reduced | None | Resolved | | |
| Event Description:none |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |