Non Serious Adverse Drug Reactions Report |
Start Date:2016-08-14 End Date:2016-08-15 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C04 |
Subject No :C04-0171 | Subject Initials :SHL | DOB :08/17/1987 | Sex:Female | Race:Asian | Height:154cm | Weight:40kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 09/29/2015 | 300 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 09/30/2015 | 10/09/2015 | | Related | Mild |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Dose reduced | None | Resolved | | |
Event Description:none |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:No |
Condition | Start Date | Related to study condition | Ongoing |