Non Serious Adverse Drug Reactions Report |
| Start Date:2016-09-20 End Date:2016-09-21 |
| Study :EMR200136_583 | Investigator :NA | Country of Investigator :Romania | SiteNo:001 |
| Subject No :001-0017 | Subject Initials : | DOB :07/31/1982 | Sex:Female | Race:Caucasian | Height:165(cm) | Weight:68(kg) |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Visit 2 (Month 3) | 03/06/2015 | 9 | |
| Visit 5 (Month12)/Early Termination | | | |
| Visit 3 (Month 6) | 03/06/2015 | 9 | |
| Visit 1/ Baseline (Day 1) | 03/06/2015 | 9 | |
| Visit 4 (Month 9) | 03/06/2015 | 9 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| inconstant flu-like symptoms | 03/06/2015 | 03/24/2016 | | Suspected | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | Concomitant medication | Resolved | | |
| Event description: |
| Subject received concomitant medications:Yes |
| Name of medication | Start Date | Ongoing | End Date | Dose | Unit | Frequency |
| ciprinol | 06/02/2015 | | 06/04/2015 | 1000 | mg | daily |
| acetaminofen | 03/06/2015 | Yes | | 200 | mg | per week |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| polycystic ovaries | | | Yes |
| ovarian insufficiency | | | Yes |
| dyslipidemia | | | Yes |
| right eye post-traumatic cataract surgery | | | No |
| synovial chist excision | | | No |