Non Serious Adverse Drug Reactions Report |
| Start Date:2016-08-25 End Date:2016-08-26 |
| Study :EMR200136_583 | Investigator :NA | Country of Investigator :Romania | SiteNo:001 |
| Subject No :001-0009 | Subject Initials : | DOB :08/08/1960 | Sex:Female | Race:Caucasian | Height:160(cm) | Weight:65(kg) |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Visit 2 (Month 3) | 12/22/2014 | 44 | |
| Visit 5 (Month12)/Early Termination | | | |
| Visit 3 (Month 6) | 12/22/2014 | 44 | |
| Visit 1/ Baseline (Day 1) | 12/22/2014 | 44 | |
| Visit 4 (Month 9) | 12/22/2014 | 44 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| injection site inflammation | 12/22/2014 | 01/01/2015 | | Suspected | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | None | Resolved | | |
| Event description: |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| persistent flu-like symptoms | 12/22/2014 | UK-unk-2014 | | Suspected | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Not applicable | None | Resolved | | |
| Event description: |
| Subject received concomitant medications:Yes |
| Name of medication | Start Date | Ongoing | End Date | Dose | Unit | Frequency |
| acetaminophen | Uk-Feb-2015 | | Uk-Feb-2015 | 500 | mg | per day |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| hypertension | | | Yes |
| dyslipidemia | | | Yes |
| acute bronchitis | | | No |
Non Serious Adverse Drug Reactions Report |
| Start Date:2016-08-25 End Date:2016-08-26 |
| Study :EMR200136_583 | Investigator :NA | Country of Investigator :Romania | SiteNo:005 |
| Subject No :005-0007 | Subject Initials : | DOB :05/06/1966 | Sex:Female | Race:Caucasian | Height:165(cm) | Weight:70(kg) |
| First administration date of batch : | Batch number : |
| Study Drug | Start Date | Dose | Change in Dose |
| Visit 5 (Month12)/Early Termination | | | |
| Visit 1/ Baseline (Day 1) | 03/05/2015 | 9 | |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| . 1.local erythema, pain | 04/10/2015 | | | Suspected | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Drug withdrawn | Led to study termination | Ongoing | | |
| Event description: |
| Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
| induration local site injection | 03/25/2015 | | | Suspected | Mild |
| Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
| None(Othervalue:) | Drug withdrawn | Led to study termination | Ongoing | | |
| Event description: |
| Subject received concomitant medications |
| Name of medication | Start Date | Ongoing | End Date | Dose | Unit | Frequency |
| Does the subject have any relevant past or present medical conditions:Yes |
| Condition | Start Date | Related to study condition | Ongoing |
| caesarean section | | | No |
| uterine fibromas | | | Yes |