Non Serious Adverse Drug Reactions Report |
Start Date:2015-10-14 End Date:2015-10-21 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0111 | Subject Initials :CXW | DOB :10/10/1979 | Sex:Female | Race:Asian | Height:162cm | Weight:68.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/20/2015 | 200 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | | | | 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:Moderate OHSS patients, improved canceled after embryo transfer. |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
Ectopic pregnancy laparoscopic surgery, the left fallopian tube embryo window. | Uk-Unk-2012 | Not on treatment/medication | |
Tubal lipiodol angiography | Uk-Unk-2013 | Not on treatment/medication | |
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