Non Serious Adverse Drug Reactions Report |
Start Date:2015-11-27 End Date:2015-12-04 |
Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
Subject No :C05-0132 | Subject Initials :HQL | DOB :07/16/1980 | Sex:Female | Race:Asian | Height:166cm | Weight:57kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 08/27/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 09/09/2015 | 09/16/2015 | | Related | Mild |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
Disease under study**(Othervalue:) | Dose not changed | None | 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 |
Fallopian tube repair anaplasty | UK-Unk-2011 | Not on treatment/medication | |
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