Non Serious Adverse Drug Reactions Report |
| Start Date:2016-09-23 End Date:2016-09-24 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C04 |
| Subject No :C04-0127 | Subject Initials :LQT | DOB :06/28/1993 | Sex:Female | Race:Asian | Height:156cm | Weight:50g |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | | | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| spontaneous abotion | 10/28/2015 | 10/28/2015 | | 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:No |
| Condition | Start Date | Related to study condition | Ongoing |