Non Serious Adverse Drug Reactions Report |
| Start Date:2016-07-11 End Date:2016-07-12 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :Korea | SiteNo:K01 |
| Subject No :k01-035 | Subject Initials :PSS | DOB :01/19/1983 | Sex:Female | Race:Asian | Height:161cm | Weight:56g |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 03/11/2015 | 225 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 03/23/2015 | 04/21/2015 | | Related | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Dose not changed | None | Resolved | | |
| Event Description: no addtional data |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:No |
| Condition | Start Date | Related to study condition | Ongoing |