Non Serious Adverse Drug Reactions Report |
| Start Date:2015-06-01 End Date:2015-06-03 |
| Study :EMR700623-541 | Investigator :NA | Country of Investigator :Korea | SiteNo:K01 |
| Subject No :k01-049 | Subject Initials :PGR | DOB :02/20/1983 | Sex:Female | Race:Asian | Height:168cm | Weight:62kg |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Gonal-f New Pen Stimulation Treatment | 05/02/2015 | 300 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| OHSS | 05/13/2015 | 05/29/2015 | | Related | Moderate |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Dose not changed | Concomitant medication **,Led to study termination | Resolved | | |
| Event description: |
| Subject received concomitant medications: |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| laparoscopic ovary cystectomy | UK-UKN-2004 | Not on treatment/medication | |
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