Non Serious Adverse Drug Reactions Report |
| Start Date:2016-06-23 End Date:2016-06-24 |
| Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
| Subject No :C05-0001 | Subject Initials :XFZ | DOB :01/21/1988 | Sex:Female | Race:Asian | Height:159cm | Weight:50kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 08/01/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 08/16/2015 | 08/18/2015 | | Related | Severe |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | None | Resolved | | |
| Event Description:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml，ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| oophorocystectomy | UK-Jul-2013 | Not on treatment/medication | |
| salpingoplasty | UK-Feb-2014 | Not on treatment/medication | |
| salpingitis after previous tubal occlusion | UK-Feb-2014 | Not on treatment/medication | Ongoing |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-06-23 End Date:2016-06-24 |
| Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
| Subject No :C05-0021 | Subject Initials :FYZ | DOB :08/28/1990 | Sex:Female | Race:Asian | Height:150cm | Weight:45kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 08/04/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 08/19/2015 | 08/21/2015 | | Related | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| Protocol procedure**,Concomitant medication**(Othervalue:) | Not applicable | None | Resolved | | |
| Event Description:abdominal distention;Drug：Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml，ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 19-Aug-2015 / 21-Aug-2015 |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| salpingocatheterism | UK-Unk-2012 | Not on treatment/medication | |