Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-14 End Date:2016-07-15 |
| Study :EMR700623-541 | Investigator :Fei Gong | Country of Investigator :China | SiteNo:C01 |
| Subject No :C01-0068 | Subject Initials :X-S | DOB :04/16/1989 | Sex:Female | Race:Asian | Height:160cm | Weight:2500g |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 06/27/2015 | 150 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 07/23/2015 | 08/04/2015 | | Related | Severe |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Concomitant procedure** | Resolved | | |
| Event Description:Abdominal distension, Nausea, yellow urine with less volume, chest pelvic effusion，Ascites puncture 23Jul2015,1000ml; 27Jul2015,2100ml; 30Jul2015,2500ml; 04Aug2015,2000ml； |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| The left Hydrosalpinx and adhesions,less patency.Right fallopian tube partially blocked | 03/22/2014 | Not on treatment/medication | Ongoing |
| right fallopian tube resection because of Ectopic pregnancy | UK-Oct-2011 | Not on treatment/medication | |